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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 15-47
ISO 22442-3 First edition 2007-12-15
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents.
This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.

NOTE 1 Analysis and management of risk is described in ISO 22442-1. Conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy. Selective sourcing is extremely important (see ISO 22442-1 and ISO 22442-2).

NOTE 2 ISO 11135, ISO 11137, ISO 11737-1, ISO 13408, ISO 14160, ISO 14937 and ISO 17665 may be relevant for bacteria, moulds and yeast (see Bibliography).

This part of ISO 22442 does not cover the utilization of human tissues in medical devices.

This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices.

NOTE 3 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form part of a quality management system conforming to ISO 13485.

This part of ISO 22442 does not consider the effect of any method of elimination and/or inactivation on the suitability of the medical device for its intended use.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 807, 812, 814, 820 and 21 CFR 58
Relevant FDA Guidance and/or Supportive Publications*
Guidance for FDA Reviewers and Industry - Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) issued November 6, 1998

Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance - Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh issued March 2, 1999

Guidance for Industry and FDA Staff: Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), Issued March 2019

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile. Guidance for Industry and Food and Drug Administration Staff. Issued on January 21, 2016.

WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies Updated 2010.

World Organization for Animal Health (OIE, formerly the Office International Epizooties) Terrestrial Animal Health Code, Chapter 11.4 Bovine Spongiform Encephalopathy. http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm

List of Bovine Spongiform Encephalopathy Risk Status of Member Countries. http://www.oie.int/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status

Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Product; Final Rule by Animal and Plant Health Inspecition Service, USDA. Federal Register Vol. 78, No 233, 72980-73088.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Scott McNamee
 David Asher
  240-402-9367 ext: 9367
 Cynthia Chang
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Tissue Engineering
*These are provided as examples and others may be applicable.