NF EN ISO 22442-1
NF EN ISO 22442-1

NF EN ISO 22442-1

December 2020
Standard Current

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

Le présent document s''applique aux dispositifs médicaux autres que les dispositifs médicaux de diagnostic in vitro, dans la fabrication desquels entrent des matériaux d''origine animale non viables ou rendus non viables. Associé à la NF EN ISO 14971, il spécifie un mode opératoire permettant d''identifier les dangers et les situations dangereuses associés à de tels dispositifs, d''estimer et d''évaluer les risques qui en découlent, de maîtriser ces risques et de surveiller l''efficacité de cette maîtrise.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2020

Number of pages

40 p.

Reference

NF EN ISO 22442-1

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Print number

1

International kinship

ISO 22442-1:2020

European kinship

EN ISO 22442-1:2020
Sumary
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

Le présent document s''applique aux dispositifs médicaux autres que les dispositifs médicaux de diagnostic in vitro, dans la fabrication desquels entrent des matériaux d''origine animale non viables ou rendus non viables. Associé à la NF EN ISO 14971, il spécifie un mode opératoire permettant d''identifier les dangers et les situations dangereuses associés à de tels dispositifs, d''estimer et d''évaluer les risques qui en découlent, de maîtriser ces risques et de surveiller l''efficacité de cette maîtrise.
Replaced standards (1)
NF EN ISO 22442-1
NF EN ISO 22442-1
July 2016
Standard Cancelled
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

Le présent document s''applique aux dispositifs médicaux autres que les dispositifs médicaux de diagnostic in vitro, dans la fabrication desquels entrent des matériaux d''origine animale non viables ou rendus non viables. Associé à l''ISO 14971, il spécifie un mode opératoire permettant d''identifier les dangers et les situations dangereuses associés à de tels dispositifs, d''estimer et d''évaluer les risques qui en découlent, de maîtriser ces risques et de surveiller l''efficacité de cette maîtrise.

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