ONORM EN ISO 14160 : 2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 14160:2011)
15-10-2021
12-01-2013
1 Scope
2 Normative references
3 Definitions
4 General
5 Validation
6 Process control and monitoring
7 Product release from sterilization
Annexes
A Guidance
B References to European Standards with their relevant
equivalents
C Bibliography
Defines requirements for developing, validating, process control and monitoring of the sterilization, using liquid chemical sterilants, of single-use medical devices consisting either entirely or partly of materials of animal origin. Not applicable to material of human origin.
| Committee |
TC 215
|
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| BS EN ISO 14160:2011 | Identical |
| UNE-EN ISO 14160:2012 | Identical |
| SN EN ISO 14160 : 2011 | Identical |
| NBN EN ISO 14160 : 2011 | Identical |
| UNI EN ISO 14160 : 2011 | Identical |
| NEN EN ISO 14160 : 2011 | Identical |
| EN ISO 14160:2011 | Identical |
| I.S. EN ISO 14160:2011 | Identical |
| DIN EN ISO 14160:2011-10 | Identical |
| NS EN ISO 14160 : 2011 | Identical |
| NF EN ISO 14160 : 2011 | Identical |
| ISO 14160:2011 | Identical |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.