🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 22442-2:2020

BS EN ISO 22442-2:2020

$142.49

Medical devices utilizing animal tissues and their derivatives – Controls on sourcing, collection and handling

Published By Publication Date Number of Pages
BSI 2020 28
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1.

NOTE

Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.

This document does not cover the utilization of human tissues in medical devices.

This document does not specify a quality management system for the control of all stages of production of medical devices.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC as amended by Commission Regulation (EU) No 722/2012
8 Foreword
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
12 4 General requirements
4.1 General
4.2 Quality system elements
13 4.3 Procedures
4.4 Personnel
14 4.5 Current regulatory requirements and guidance
5 Sourcing
5.1 General
5.2 Species and strain
5.3 Geography
15 5.4 Inspection
5.5 Certification
5.6 Traceability
16 6 Collection
7 Handling
8 Storage, transport and labelling
18 Annex A (normative) Additional requirements relating to the application of this document to bovine-sourced materials and other TSE relevant animal species
24 Annex B (informative) Certification and attestation
26 Bibliography

Related products

BS EN ISO 22442-2:2020
$142.49