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Sterilization of health-care products - Ethyle...
+ 1 Scope
2 Normative references
+ 3 Terms and definitions
+ 4 Quality management system
+ 5 Sterilizing agent characterization
+ 6 Process and equipment characterization
+ 7 Product definition
+ 8 Process definition
+ 9 Validation
+ 10 Routine monitoring and control
+ 11 Product release from sterilization
+ 12 Maintaining process effectiveness
+ Annex A
A.1 Scope
A.2 Normative references
A.3 Terms and definitions
+ A.4 Quality management systems
+ A.5 Sterilizing agent characterization
+ A.6 Process and equipment characterization
+ A.7 Product definition
+ A.8 Process definition
+ A.9 Validation
+ A.10 Routine monitoring and control
+ A.11 Product release from sterilization
+ A.12 Maintaining process effectiveness
+ Annex B
B.1 General
+ B.2 Considerations for PCD design and preparati...
+ B.3 Types of PCDs
+ B.4 Establishing appropriateness of a PCD
B.5 Microbiological challenge assessment
+ B.6 Comparison of challenges presented by diffe...
+ Table B.1 — Comparison of percent positives to ...
B.6.5
+ Annex C
+ C.1 Temperature sensors
+ C.2 Humidity sensors
+ C.3 Process challenge devices
+ Annex D
+ D.1 Overview
+ D.2 Operational qualification (OQ)
+ D.3 Cycle parameter considerations and recommen...
+ D.4 Humidity and EO concentration measurement e...
+ D.5 Equipment requalification
D.6 Assessment of impact of change
+ Annex E
E.1 General
+ E.2 Procedure
+ Annex F
+ F.1 General
F.2 Process definition
+ F.3 Biological indicator and bioburden method
+ F.4 Overkill methods
+ Annex G
G.1 General
+ G.2 Important considerations when calculating D...
+ G.3 Cycle calculation methods
+ G.4 BI/bioburden cycle calculation method
+ G.5 Requalification
+ Annex H
H.1 General
+ H.2 Establishing cycle specification for parame...
+ Annex I
I.1 General
+ I.2 Establishing process specification
+ I.3 Evaluation of cycle deviations
+ Annex J
+ J.1 Process equivalence
+ J.2 Product equivalence
+ Annex ZA
Table ZA.1 — Correspondence between this Europe...
Table ZA.2 — Applicable Standards to confer pre...
Table ZA.3 — Terms and definitions from clause ...
+ Annex ZB
Table ZB.1 — Correspondence between this Europe...
Table ZB.2 — Applicable Standards to confer pre...
Table ZB.3 — Terms and definitions from clause ...

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025)

Oznaka:prEN ISO 11135

Odbor:HZN/TO 555

Ime odbora:Medicinski proizvodi

Nacrt objavljen za komentiranje:2025-07-10

Rok za komentiranje:2025-08-17

Broj komentara:0

Contact email:nacrti(at)hzn.hr

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Područje primjene nacrta:

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

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