British Standards Institution

Source:: ISO
Committee:: CH/210 - Quality management and corresponding general aspects for medical devices
Categories:: Medical equipment. General

Comment on proposal

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How important do you think standardization is in this area? *

Do you agree that a standard on this subject is feasible?: *

Please give reasons for your selections above: *

Would you or your organization use the standard? *

Would you or your organization be prepared to participate in the development of the standard or to comment on the draft when it is available? *

Are you aware of any regulation, existing standards and other good practice information in this area in the UK (e.g. Industry codes of practice; company specifications, international or European Standards)? *

Would the development of a standard(s) in this area have a particular impact/relevance to SME, consumer, environmental or societal interests? *

Are you aware of any other organizations to which this proposal may be relevant? If so please provide details below. *

Additional comments on the scope or proposal:

Although BSI will not usually enter into correspondence regarding individual comments or suggestions we may wish to contact you to seek further clarification. Please indicate whether this will be acceptable: *

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

14/11/2013

3. Public Comments (Complete)

Public Comments start date:

07/03/2014

Public Comments end date:

13/11/2014

Learn more about the standards development process

Standards Development

BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards - (Withdrawn Standard)

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