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发帖数: 1652 | 1 http://en.wikipedia.org/wiki/ISO_13485
ISO 13485 is an ISO standard, published in 2003, that represents the
requirements for a comprehensive management system for the design and
manufacture of medical devices [1][clarification needed]. This standard
supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the
ISO 13485 published in 1996 and ISO 13488(also 1996).
While it remains a stand-alone document, ISO 13485 is generally harmonized
with ISO 9001. A fundamental difference, however, is that ISO 9001 requires
the organization to demonstrate continual improvement, whereas ISO 13485
requires only that they demonstrate the quality system is implemented and
maintained.
Other specific differences include:
the promotion and awareness of regulatory requirements as a management
responsibility. An example of market specific regulatory requirements is 21
CFR 820 Quality System Regulation for Medical Devices sold in the United
States.
controls in the work environment to ensure product safety
focus on risk management activities and design transfer activities during
product development
specific requirements for inspection and traceability for implantable
devices
specific requirements for documentation and validation of processes for
sterile medical devices
specific requirements for verification of the effectiveness of corrective
and preventive actions
Compliance with ISO 13485 is often seen as the first step in achieving
compliance with European regulatory requirements. The conformity of Medical
Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/
42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted.
The preferred method to prove conformity is the certification of the Quality
Management System according ISO 9001 and/or ISO 13485 and ISO 14971 by a
Notified Body. The result of a positive assessment is the certificate of
conformity allowing the CE marking and the permission to sell the medical
device in the European Union.
This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with
respect to the European medical device directives 93/42/EEC, 90/385/EEC and
98/79/EC. | s**********8
发帖数: 25265 | 2 学习了.
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: http://en.wikipedia.org/wiki/ISO_13485
: ISO 13485 is an ISO standard, published in 2003, that represents the
: requirements for a comprehensive management system for the design and
: manufacture of medical devices [1][clarification needed]. This standard
: supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the
: ISO 13485 published in 1996 and ISO 13488(also 1996).
: While it remains a stand-alone document, ISO 13485 is generally harmonized
: with ISO 9001. A fundamental difference, however, is that ISO 9001 requires
: the organization to demonstrate continual improvement, whereas ISO 13485
: requires only that they demonstrate the quality system is implemented and
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