CAN/CSA-ISO 13485-98:2000

Quality systems - Medical devices - Particular requirements for the application of ISO 9001

CAN/CSA-ISO 13485-98:2000 发布历史

CAN/CSA-ISO 13485-98:2000由SCC 发布于 2000-01-01。

CAN/CSA-ISO 13485-98:2000在国际标准分类中归属于: 03.120.10 质量管理和质量保证。

CAN/CSA-ISO 13485-98:2000 的最新版本是哪一版？

最新版本是 CAN/CSA-ISO 13485-98:2000 。

CAN/CSA-ISO 13485-98:2000的历代版本如下：

• 2000年 CAN/CSA-ISO 13485-98:2000

This National Standard of Canada is equivalent to International Standard ISO 13485:1996. 1 Scope This International Standard specifies, in conjunction with ISO 9001, the quality system requirements for the design/development, production and, when relevant, installation and servicing of medical devices. This International Standard, in conjunction with ISO 9001, is applicable when there is a need to assess a medical device supplier's quality system. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this International Standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention. NOTE - In this International Standard the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the supplier can document a justification otherwise. a requirement is considered "appropriate" if its non-implementation could result in - the product not meeting its specified requirements, and/or - the supplier being unable to carry out corrective action.

标准号

CAN/CSA-ISO 13485-98:2000

发布

2000年

发布单位

SCC

当前最新

CAN/CSA-ISO 13485-98:2000

 

 

代替标准

MEDICAL EQUIPMENT, MEDICAL DEVICES, QUALITY ASSURANCE, QUALITY ASSURANCESYSTEMS, DESIGN, DEVELOPMENT (WORK), PRODUCTION, INSTALLATION, AFTER-SALESERVICES, SPECIFICATIONS, DETAIL SPECIFICATIONS, IMPLEMENTATION

被代替标准

CAN/CSA-ISO 13485:03

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