British Standards Institution

Source:: ISO
Committee:: CH/210 - Quality management and corresponding general aspects for medical devices
Categories:: Information management | Standardization. General rules | Healthcare | Medical equipment | Medical equipment. General | Medical equipment. Other

Scope

This standard specifies requirements on good maintenance management of active medical devices.

This standard applies to active medical devices placed for use in any healthcare facility or any other facility which requires maintenance.

This standard is not applicable to any device not intended to be used on humans.

Purpose

The intended standard is a reference for medical devices during their life-cycle upon being placed for use to ensure:

• their functioning in the intended manner;

• continued safety for the patient and the user; and

• interruptions of use are minimized.

In Malaysia, the standard has been mandatory as a national standard since 2008. The abovementioned benefits have been confirmed in practice. Developing the material as ISO standard will make the benefits accessible to the international community.

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: *

Discard

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

Standard timeline

1. Proposal

Proposal start date:

25/03/2020

Proposal end date:

29/05/2020

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/TC 210 N 1167, ISO/NP 5137 Active Medical Device - Good Engineering Maintenance Management

Scope

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