Thursday, August 1, 2013

New Medical Equipment in General Standards for the 2nd Quarter 2013

Document Center Inc. is pleased to announce that the following New Standards on Medical Equipment in General are now available:

  • ASTM F2503, 2013 Edition, 2013 Edition, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
  • BS EN 60601-1-8, 2007 Edition with Amendment 1, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • DIN EN ISO 14971, 2013 Edition, Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • ISO/TR 24971, 1st Edition, Medical devices - Guidance on the application of ISO 14971
  • BIP 3083, Withdrawn and replaced by BS EN ISO 15223-1, CD Rom format, Graphical symbols for use in the labelling of medical devices CD-ROM

For more standards on this topic, please see our Document Center List of Standards on Medical Equipment in General.

Over the years, medical device manufacturers have become an important part of our customer mix.  The regulatory environment for these clients is quite stringent, with governing bodies around the world specifying various certification schemes.

When any company is subject to both regulatory oversight and severe legal consequences for equipment failure, there can be no room for error in the required documentation.  That's why so many medical device manufacturers rely on Document Center Inc. to monitor their standards collections.

As you can see, Document Center not only sells and tracks the documents our customers know they need, we also provide them with services like this blog and our Standards Informer current awareness service.  We want our clients to be assured that they are fully informed about the changes to the requirements in their given fields.

If you want more from your Standards Service, consider Document Center.  We've been working with standards since 1982.  Make us Your Standards Experts!