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  ISO 13485:1996

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Author Topic:   ISO 13485:1996
Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
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posted 01 May 2000 03:36 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Is anyone familiar with this?

ISO 13485:1996
Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001

Edition: 1 (Monolingual)
Number of pages: 10
Technical committee / subcommittee: TC 210
ICS: 03.120.10, 11.040.01
Stage: 60.60
Stage date: 1996-12-26

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Christian Lupo
Forum Contributor

Posts: 117
From:Auburn, NY
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posted 01 May 2000 09:40 AM     Click Here to See the Profile for Christian Lupo   Click Here to Email Christian Lupo     Edit/Delete Message   Reply w/Quote
This document is ISO-9000 series with a few additions particular to the medical device industry. The major additions are in section 4.9, and address housekeeping, cleanliness, and PM.

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Wallybaloo
Forum Contributor

Posts: 16
From:Oregon
Registered: Apr 2000

posted 01 May 2000 01:10 PM     Click Here to See the Profile for Wallybaloo   Click Here to Email Wallybaloo     Edit/Delete Message   Reply w/Quote
Christian's got it. Also keep in mind that how much of it applies to your situation depends on the classification of the devices you make. Some of it only applies if your product is active (powered) and/or implantable. The definitions at the front help a lot.

ISO 13485 is based on, and very similar to, EN 46001, which seems to be slowly fading.

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