Tuesday, February 23, 2016

New Sterilization and Disinfection Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Sterilization and Disinfection for the Healthcare Industry are now available:


  • ASTM E1766, 2015 Edition, Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
  • ASTM E1891, 2010a Edition Reapproved in 2015, Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient
  • ASTM E2752, 2010 Edition Reapproved in 2015, Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products
  • BS EN 13727, 2012 Edition with Amendment A2, Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity in the medical area. Test method and requirements (phase 2, step 1)
  • BS EN 14476, 2013 Edition with Amendment A1, Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1)
  • DIN EN 556-2, 2015 Edition, Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 2: Requirements for aseptically processed medical devices (English Language Edition)
  • DIN EN 14885, 2015 Edition, Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics (English Language Edition)
  • DIN EN ISO 11137-1, 2015 Edition, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (English Language Edition)


For more standards like these, please see our Document Center List of Standards on Sterilization and Disinfection for the Healthcare Industry.  A number of links will direct you to the various sub-sets for this classification.

You're also welcome to take a look at my previous post:

Friday, February 19, 2016

New Toy and Other Entertainment Equipment Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Toys and Other Entertainment Equipment are now available:


  • ASTM F747, 2015 Edition, Standard Terminology Relating to Amusement Rides and Devices
  • ASTM F1159, 2015b Edition, Standard Practice for Design of Amusement Rides and Devices
  • ASTM F1193, 2015 Edition, Standard Practice for Quality, Manufacture, and Construction of Amusement Rides and Devices
  • ASTM F2137, 2015a Edition, Standard Practice for Measuring the Dynamic Characteristics of Amusement Rides and Devices
  • ASTM F2291, 2015 Edition, Standard Practice for Design of Amusement Rides and Devices
  • ASTM F2974, 2015 Edition, Standard Guide for Auditing Amusement Rides and Devices
  • BS EN 581-2, 2015 Edition, Outdoor furniture. Seating and tables for camping, domestic and contract use. Mechanical safety requirements and test methods for seating
  • ISO 8124-7, 1st Edition, Safety of toys - Part 7: Requirements and test methods for finger paints
  • ISO 8124-8, 2nd Edition, Safety of toys - Part 8: Age determination guidelines


For more standards like these, please see our Document Center List of Standards on Toys and Other Entertainment Equipment.  You'll follow the links to the various topic areas.

You may also want to take a look at my previous post:

Thursday, February 18, 2016

New Ignitability and Burning Behavior of Materials and Products for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Ignitability and Burning Behavior of Materials and Products are now available:


  • ASTM D93, 2015a Edition, Standard Test Methods for Flash Point by Pensky-Martens Closed Cup Tester
  • ASTM D2859, 2015 Edition, Standard Test Method for Ignition Characteristics of Finished Textile Floor Covering Materials
  • ASTM D6890, 2015b Edition, Standard Test Method for Determination of Ignition Delay and Derived Cetane Number (DCN) of Diesel Fuel Oils by Combustion in a Constant Volume Chamber
  • ASTM E662, 2015a Edition, Standard Test Method for Specific Optical Density of Smoke Generated by Solid Materials
  • ASTM E1537, 2015 Edition, Standard Test Method for Fire Testing of Upholstered Furniture
  • ASTM E2102, 2015 Edition, Standard Test Method for Measurement of Mass Loss and Ignitability for Screening Purposes Using a Conical Radiant Heater
  • ASTM E2536, 2015a Edition, Standard Guide for Assessment of Measurement Uncertainty in Fire Tests
  • ASTM G72, 2015 Edition, Standard Test Method for Autogenous Ignition Temperature of Liquids and Solids in a High-Pressure Oxygen-Enriched Environment
  • ASTM G125, 2000 Edition Reapproved in 2015, Standard Test Method for Measuring Liquid and Solid Material Fire Limits in Gaseous Oxidants
  • ASTM G128, 2015 Edition, Standard Guide for Control of Hazards and Risks in Oxygen Enriched Systems
  • BS EN 50200, 2015 Edition, Method of test for resistance to fire of unprotected small cables for use in emergency circuits
  • BS EN 50265-2-1, Withdrawn and replaced by BS EN 60332-1-2, Common test methods for cables under fire conditions. Test for resistance to vertical flame propagation for a single insulated conductor or cable. Procedures. 1 kW pre-mixed flame. 1 kW pre-mixed flame
  • BS EN 60332-1-1, 2004 Edition with Amendment A1, Tests on electric and optical fibre cables under fire conditions. Test for vertical flame propagation for a single insulated wire or cable. Apparatus
  • BS EN 60332-1-2, 2004 Edition with Amendment A1, Tests on electric and optical fibre cables under fire conditions. Test for vertical flame propagation for a single insulated wire or cable. Procedure for 1 kW pre-mixed flame
  • BS EN 60332-1-3, 2004 Edition with Amendment A1, Tests on electric and optical fibre cables under fire conditions. Test for vertical flame propagation for a single insulated wire or cable. Procedure for determination of flaming droplets/particles
  • BS EN 60695-1-11, 2015 Edition, Fire hazard testing. Guidance for assessing the fire hazard of electrotechnical products. Fire hazard assessment
  • DIN EN 12881-1, 2015 Edition, Conveyor belts - Fire simulation flammability testing - Part 1: Propane burner tests (English language edition)


Wednesday, February 17, 2016

New Clothing Industry Standards for 2015

Document Center Inc. is pleased to announce that the following New Standards for the Clothing Industry are now available:

  • ASTM D2052, 2005 Edition Reapproved in 2015, Standard Test Method for Colorfastness of Zippers to Drycleaning
  • ASTM D2053, 1999 Edition Reapproved in 2015, Standard Test Method for Colorfastness of Zippers to Light
  • ASTM D2054, 1999 Edition Reapproved in 2015, Standard Test Method for Colorfastness of Zipper Tapes to Crocking
  • ASTM D2057, 2005 Edition Reapproved in 2015, Standard Test Method for Colorfastness of Zippers to Laundering
  • ASTM D2060, 2014 Edition with an Editorial Correction, Standard Test Methods for Measuring Zipper Dimensions
  • ASTM D3181, 2015 Edition with an Editorial Correction, Standard Guide for Conducting Wear Tests on Textiles
  • ASTM D4118, 2015 Edition, Standard Performance Specification for Women's Woven Coverall, Dungaree, Overall, and Shop-Coat Fabrics
  • ASTM D4465, 2005 Edition Reapproved in 2015, Standard Performance Specification for Zippers for Dungarees, Jeans and Work Trousers
  • ASTM D4679, 2002 Edition Reapproved in 2015 with an Editorial Correction, Standard Specification for Rubber General Purpose, Household or Beautician Gloves
  • ASTM D5170, 1998 Edition Reapproved in 2015, Standard Test Method for Peel Strength ('T' Method) of Hook and Loop Touch Fasteners
  • ASTM D5171, 2015 Edition, Standard Test Method for Impact Resistance of Plastic Sew-Through Buttons
  • ASTM D5219, 2015 Edition, Standard Terminology Relating to Body Dimensions for Apparel Sizing
  • ASTM D6829, 2002 Edition Reapproved in 2015, Standard Tables of Body Measurements for Juniors, Sizes 0 to 19
  • ASTM F1291, 2015 Edition, Standard Test Method for Measuring the Thermal Insulation of Clothing Using a Heated Manikin
  • ASTM F2298, Withdrawn, No replacement, Standard Test Methods for Water Vapor Diffusion Resistance and Air Flow Resistance of Clothing Materials Using the Dynamic Moisture Permeation Cell (Withdrawn 2015)
  • ASTM F2370, 2015 Edition, Standard Test Method for Measuring the Evaporative Resistance of Clothing Using a Sweating Manikin
  • BS EN 16732, 2015 Edition, Slide fasteners (zips). Specification
  • DIN EN 14682, 2015 Edition, Safety of children's clothing - Cords and drawstrings on children's clothing - Specifications (English language)
  • ISO 10750, 1st Edition, Footwear - Test method for slide fasteners - Attachment strength of end stops
  • ISO 19407, 1st Edition, Footwear - Sizing - Conversion of sizing systems
  • ISO 19408, 1st Edition, Footwear - Sizing - Vocabulary and terminology


For more standards like these, please see our Document Center List of Standards for the Clothing Industry and following the links to those areas that interest you.

Tuesday, February 16, 2016

New Surface Treatment And Coating Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Surface Treatments And Coatings are now available:


  • ASTM A123, 2015 Edition, Standard Specification for Zinc (Hot-Dip Galvanized) Coatings on Iron and Steel Products
  • ASTM A385, 2015 Edition, Standard Practice for Providing High-Quality Zinc Coatings (Hot-Dip)
  • ASTM B607, 2015 Edition, Standard Specification for Autocatalytic Nickel Boron Coatings for Engineering Use
  • ASTM B633, 2015 Edition, Standard Specification for Electrodeposited Coatings of Zinc on Iron and Steel
  • ASTM B636, 2015 Edition, Standard Test Method for Measurement of Internal Stress of Plated Metallic Coatings with the Spiral Contractometer
  • ASTM B679, 1998 Edition Reapproved in 2015, Standard Specification for Electrodeposited Coatings of Palladium for Engineering Use
  • ASTM B733, 2015 Edition, Standard Specification for Autocatalytic (Electroless) Nickel-Phosphorus Coatings on Metal
  • ASTM D3288, 2015 Edition, Standard Test Methods for Magnet-Wire Enamels
  • ASTM D4940, 2015 Edition, Standard Test Method for Conductimetric Analysis of Water Soluble Ionic Contamination of Blast Cleaning Abrasives
  • ASTM D5162, 2015 Edition, Standard Practice for Discontinuity (Holiday) Testing of Nonconductive Protective Coating on Metallic Substrates
  • ASTM F1178, 2011 Edition Reapproved in 2015, Standard Specification for Performance of Enameling System, Baking, Metal Joiner Work and Furniture
  • ASTM F1941, 2015 Edition, Standard Specification for Electrodeposited Coatings on Mechanical Fasteners, Inch and Metric (Now designated as ASTM F1941/F1941M, which also replaces ASTM F1941)
  • ASTM G100, 1989 Edition Reapproved in 2015, Standard Test Method for Conducting Cyclic Galvanostaircase Polarization
  • ASTM G116, 1999 Edition Reapproved in 2015, Conducting Wire-on-Bolt Test for Atmospheric Galvanic Corrosion
  • BS EN 14430, Withdrawn and replaced by BS EN ISO 2746, Vitreous and porcelain enamels. High voltage test
  • BS EN ISO 2746, 2015 Edition, Vitreous and porcelain enamels. High voltage test
  • BS EN ISO 12670, Corrigendum 1 for 2011 Edition, Thermal spraying. Components with thermally sprayed coatings. Technical supply conditions
  • BS EN ISO 12679, Corrigendum 1 for 2012 Edition, Thermal spraying. Recommendations for thermal spraying
  • BS EN ISO 28721-4, 2015 Edition, Vitreous and porcelain enamels. Glass-lined apparatus for process plants. Quality requirements for glass-lined flanged steel pipes and flanged steel fittings
  • BS EN ISO 28764, 2015 Edition, Vitreous and porcelain enamels. Production of specimens for testing enamels on sheet steel, sheet aluminium and cast iron
  • ISO 2746, 3rd Edition, Vitreous and porcelain enamels - High voltage test
  • ISO 28721-2, 2nd Edition, Vitreous and porcelain enamels - Glass-lined apparatus for process plants - Part 2: Designation and specification of resistance to chemical attack and thermal shock
  • ISO 28721-4, 2nd Edition, Vitreous and porcelain enamels - Glass-lined apparatus for process plants - Part 4: Quality requirements for glass-lined flanged steel pipes and flanged steel fittings
  • ISO 28764, 2nd Edition, Vitreous and porcelain enamels - Production of specimens for testing enamels on sheet steel, sheet aluminium and cast iron


For more standards like these, please see our Document Center List of Standards on Surface Treatments And Coatings.  Follow the links for detailed information.

Monday, February 15, 2016

New Welding, Brazing And Soldering Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Welding, Brazing And Soldering are now available:


  • ASTM D2657, 2007 Edition Reapproved in 2015, Standard Practice for Heat Fusion Joining of Polyolefin Pipe and Fittings
  • ASTM G58, 1985 Edition Reapproved in 2015, Standard Practice for Preparation of Stress-Corrosion Test Specimens for Weldments
  • AWS D1.1/D1.1M, 2015 Edition, Structural Welding Code - Steel
  • AWS WI, 2015 Edition, Welding Inspection Handbook
  • BS EN 1711, Withdrawn and replaced by BS EN ISO 17643, Non-destructive examination of welds. Eddy current examination of welds by complex plane analysis
  • BS EN ISO 636, 2015 Edition, Welding consumables. Rods, wires and deposits for tungsten inert gas welding of non-alloy and fine-grain steels. Classification
  • BS EN ISO 1071, 2015 Edition, Welding consumables. Covered electrodes, wires, rods and tubular cored electrodes for fusion welding of cast iron. Classification
  • BS EN ISO 9018, 2015 Edition, Destructive tests on welds in metallic materials. Tensile test on cruciform and lapped joints
  • BS EN ISO 14172, 2015 Edition, Welding consumables. Covered electrodes for manual metal arc welding of nickel and nickel alloys. Classification
  • BS EN ISO 17632, 2015 Edition, Welding consumables. Tubular cored electrodes for gas shielded and non-gas shielded metal arc welding of non-alloy and fine grain steels. Classification
  • BS EN ISO 17641-2, 2015 Edition, Destructive tests on welds in metallic materials. Hot cracking tests for weldments. Arc welding processes. Self-restraint tests
  • BS EN ISO 17643, 2015 Edition, Non-destructive testing of welds. Eddy current examination of welds by complex plane analysis
  • BS EN ISO 18273, 2015 Edition, Welding consumables. Wire electrodes, wires and rods for welding of aluminium and aluminium alloys. Classification
  • DIN EN ISO 3834-5, 2015 Edition, Quality requirements for fusion welding of metallic materials - Part 5: Documents with which it is necessary to conform to claim conformity to the quality requirements of ISO 3834-2, ISO 3834-3 or ISO 3834-4 (English language)
  • ISO 636, 4th Edition, Welding consumables - Rods, wires and deposits for tungsten inert gas welding of non-alloy and fine-grain steels - Classification
  • ISO 1071, 3rd Edition, Welding consumables - Covered electrodes, wires, rods and tubular cored electrodes for fusion welding of cast iron - Classification
  • ISO 9018, 2nd Edition, Destructive tests on welds in metallic materials - Tensile test on cruciform and lapped joints
  • ISO 17632, 2nd Edition, Welding consumables - Tubular cored electrodes for gas shielded and non-gas shielded metal arc welding of non-alloy and fine grain steels - Classification
  • ISO 17641-2, 2nd Edition, Destructive tests on welds in metallic materials - Hot cracking tests for weldments - Arc welding processes - Part 2: Self-restraint tests
  • ISO 18273, 2nd Edition, Welding consumables - Wire electrodes, wires and rods for welding of aluminium and aluminium alloys - Classification


For more standards like these, please see our Document Center List of Standards on Welding, Brazing And Soldering and follow the appropriate links.

Friday, February 12, 2016

New Statistical Analysis Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on the Application of Statistical Analysis are now available:


  • ASTM E2935, 2015 Edition, Standard Practice for Conducting Equivalence Testing in Laboratory Applications
  • BS 5700, 2015 Edition, Guide to the selection of charting methods and capability assessment for use in statistical process control
  • ISO 13195, 1st Edition, Selected illustrations of response surface method - Central composite design
  • ISO 16355-1, 1st Edition, Application of statistical and related methods to new technology and product development process - Part 1: General principles and perspectives of Quality Function Deployment (QFD)
  • ISO 18404, 1st Edition, Quantitative methods in process improvement - Six Sigma - Competencies for key personnel and their organizations in relation to Six Sigma and Lean implementation


Thursday, February 11, 2016

New Heat and Calorimetry Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Heat and Calorimetry are now available:


  • ASTM C1171, 2015 Edition, Standard Test Method for Quantitatively Measuring the Effect of Thermal Shock and Thermal Cycling on Refractories
  • ASTM E2602, 2009 Edition Reapproved in 2015, Standard Test Methods for the Assignment of the Glass Transition Temperature by Modulated Temperature Differential Scanning Calorimetry
  • ASTM E2890, 2012 Edition with an Editorial Correction, Standard Test Method for Kinetic Parameters for Thermally Unstable Materials by Differential Scanning Calorimetry Using the Kissinger Method
  • BS EN 1434-1, 2015 Edition, Heat meters. General requirements
  • BS EN 1434-2, 2015 Edition, Heat meters. Constructional requirements
  • BS EN 1434-3, 2015 Edition, Heat meters. Data exchange and interfaces
  • BS EN 1434-4, 2015 Edition, Heat meters. Pattern approval tests
  • BS EN 1434-5, 2015 Edition, Heat meters. Initial verification tests
  • BS EN 1434-6, 2015 Edition, Heat meters. Installation, commissioning, operational monitoring and maintenance


For more standards like these, please see our Document Center List of Standards on Heat and Calorimetry.

Wednesday, February 10, 2016

New Industrial Process Measurement and Control Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Industrial Process Measurement and Control are now available:


  • ASTM E2281, 2015 Edition, Standard Practice for Process Capability and Performance Measurement
  • BS 7500, 2015 Edition, Guide to the selection of charting methods and capability assessment for use in statistical process control
  • BS EN 61784-5-4, 2012 Edition with Amendment A1, Industrial communication networks. Profiles. Installation of fieldbuses. Installation profiles for CPF 4
  • BS EN 61784-5-10, 2012 Edition with Amendment A1, Industrial communication networks. Profiles. Installation of fieldbuses. Installation profiles for CPF 10
  • BS EN 61784-5-12, 2012 Edition with Amendment A1, Industrial communication networks. Profiles. Installation of fieldbuses. Installation profiles for CPF 12
  • BS EN 61784-5-15, 2012 Edition with Amendment A1, Industrial communication networks. Profiles. Installation of fieldbuses. Installation profiles for CPF 15
  • BS EN 61804-3, 2015 Edition, Function Blocks (FB) for process control and Electronic Device Description Language (EDDL). EDDL syntax and semantics
  • BS EN 61804-5, 2015 Edition, Function blocks (FB) for process control and electronic device description language (EDDL). EDDL Builtin library
  • BS EN 62769-103-1, 2015 Edition, Field Device Integration (FDI). Profiles. PROFIBUS
  • BS EN 62769-103-4, 2015 Edition, Field Device Integration (FDI). Profiles. PROFINET
  • IEC 60534-2-3, Edition 3.0, Industrial-process control valves - Part 2-3: Flow capacity - Test procedures
  • IEC 61804-4, Edition 1.0, Function blocks (FB) for process control and electronic device description language (EDDL) - Part 4: EDD interpretation
  • IEC 62601, Edition 2.0, Industrial networks - Wireless communication network and communication profiles - WIA-PA
  • IEC 62872, Edition 1.0, Industrial-process measurement, control and automation system interface between industrial facilities and the smart grid
  • ISO 8000-8, 1st Edition, Data quality - Part 8: Information and data quality: Concepts and measuring



You may also want to review my previous post:

Tuesday, February 9, 2016

New Transfusion, Infusion And Injection Medical Equipment for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Transfusion, Infusion And Injection Medical Equipment are now available:


  • BS EN ISO 8362-2, 2015 Edition, Injection containers and accessories. Closures for injection vials
  • BS EN ISO 23500, Corrigendum 1 for 2014 Edition, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
  • BS EN ISO 26722, Corrigendum 1 for 2014 Edition, Water treatment equipment for haemodialysis applications and related therapies
  • DIN EN ISO 8536-8, 2015 Edition, Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (English language)
  • DIN EN ISO 8536-10, 2015 Edition, Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment
  • ISO 1134-4, 6th Edition, Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
  • ISO 1134-5, 1st Edition, Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus
  • ISO 8362-1 Amendment 1 for the 3rd Edition, Amendment 1, Part 1: Injection vials made of glass tubing, Injection containers and accessories
  • ISO 8362-2, 3rd Edition, Injection containers and accessories - Part 2: Closures for injection vials



You can also take a look at my previous post:

Monday, February 8, 2016

New Microbiology Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Microbiology are now available:


  • ASTM D4454, Withdrawn without replacement, Standard Test Method for Simultaneous Enumeration of Total and Respiring Bacteria in Aquatic Systems by Microscopy (Withdrawn 2015)
  • ASTM D5952, 2008 Edition Reaffirmed in 2015, Standard Guide for the Inspection of Water Systems for Legionella and the Investigation of Possible Outbreaks of Legionellosis (Legionnaires' Disease or Pontiac Fever)
  • ASTM D6734, Withdrawn without replacement, Standard Test Method for Low Levels of Coliphages in Water (Withdrawn 2015)
  • ASTM D7463, 2015 Edition, Standard Test Method for Adenosine Triphosphate (ATP) Content of Microorganisms in Fuel, Fuel/Water Mixtures and Fuel Associated Water
  • ASTM E1326, 2015a Edition, Standard Guide for Evaluating Non-culture Microbiological Tests
  • ASTM F838, 2015a Edition, Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
  • BS EN ISO 18743, 2015 Edition, Microbiology of the food chain. Detection of Trichinella larvae in meat by artificial digestion method
  • BS EN ISO 29621, Corrigendum 2 for 2010 Edition, Cosmetics. Microbiology. Guidelines for the risk assessment and identification of microbiologically low-risk products
  • ISO 9252, Withdrawn without replacement, Synthetic rubber latex -- Microbiological examination
  • ISO 10718, 3rd Edition, Cork stoppers - Characterization of a low-in-germs stopper, through the enumeration of colony-forming units of yeasts, moulds and bacteria, capable of both being extracted and growing in alcoholic medium
  • ISO 18416, 2nd Edition, Cosmetics - Microbiology - Detection of Candida albicans
  • ISO 18867, 1st Edition, Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Detection of pathogenic Yersinia enterocolitica and Yersinia pseudotuberculosis
  • ISO 21150, 2nd Edition, Cosmetics - Microbiology - Detection of Escherichia coli
  • ISO 22717, 2nd Edition, Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa
  • ISO 22718, 2nd Edition, Cosmetics - Microbiology - Detection of Staphylococcus aureus 


For more standards like these, please see our Document Center List of Standards on Microbiology and it's links.

You can also take a look at my previous post:

Thursday, February 4, 2016

New Quality Management And Quality Assurance Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Quality Management And Quality Assurance are now available:


  • BS EN ISO 15378, 2015 Edition, Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • ISO 15378, 3rd Edition, Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • ISO/FDIS 13485, Final draft for proposed 3rd Edition, Medical Devices - Quality Management Systems - Requirements
  • ISO Guide 31, 3rd Edition, Reference materials - Contents of certificates, labels and accompanying documentation
  • JIS Q 9000, 2015 Edition, Quality Management Systems - Fundamentals and Vocabulary (Japanese language only)
  • JIS Q 9001, 2015 Edition, Quality management systems - Requirements (Japanese language only)
  • JIS Q 10002, 2015 Edition, Quality Management - Customer Satisfaction - Guidelines for Complaints Handling in Organizations (Japanese language only)
  • SS EN ISO 9001, 2015 Edition, Quality management systems - Requirements (English language edition)



You can also take a look at my previous post:

Wednesday, February 3, 2016

New Implants For Surgery, Prosthetics And Orthotics Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards for Implants For Surgery, Prosthetics And Orthotics are now available:


  • ASTM F620, 2011 Edition Reapproved in 2015, Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
  • ASTM F1781, 2015 Edition, Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
  • ASTM F2180, 2002 Edition Reapproved in 2015, Standard Specification for Metallic Implantable Strands and Cables
  • BS EN ISO 5840, Withdrawn and replaced by BS EN ISO 5840-2, Cardiovascular implants. Cardiac valve prostheses
  • BS EN ISO 5840-1, 2015 Edition, Cardiovascular implants. Cardiac valve prostheses. General requirements
  • BS EN ISO 5840-2, 2015 Edition, Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes
  • BS EN ISO 12417-1, 2015 Edition, Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. General requirements
  • BS EN ISO 13356, 2015 Edition, Implants for surgery. Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
  • BS EN ISO 13958, 2015 Edition, Concentrates for haemodialysis and related therapies
  • BS EN ISO 23500,  Corrigendum 1 for 2014 Edition, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
  • BS EN ISO 26722, Corrigendum 1 for 2014 Edition, Water treatment equipment for haemodialysis applications and related therapies
  • ISO 12417-1, 1st Edition, Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements



You can also take a look at my previous post: