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AAMI TIR37 : 2013

Current
Current

The latest, up-to-date edition.

STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-30-2013

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Definition and maintenance of product
  families for dose setting, dose substantiation
  and sterilization dose auditing
5 Selection and testing of product for establishing
  and verifying the sterilization dose
6 Methods of dose establishment
Annex A (informative) - Selection of a Dose
        Setting Method
Bibliography

Gives guidance for development, validation and routine control associated with the radiation sterilization processing of biologics and tissue-based products.

DocumentType
Standard
ISBN
1570205221
Pages
29
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

14/30266295 DC : 0 BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS
ISO 11737-1:2018 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ISO 18362:2016 Manufacture of cell-based health care products Control of microbial risks during processing
I.S. EN ISO 11737-1:2018&LC:2018 STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018)
BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing

AAMI ISO 11137-2 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
ISO/ASTM 51261:2013 Practice for calibration of routine dosimetry systems for radiation processing
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
AAMI TIR35 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT ADOPTION AND ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS
AAMI ISO TIR 11139 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION

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Hardcopy - English
PDF - English - DRM
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