EN ISO 11135:2014/AMD 1:2019- Gap Analyis

DIN EN ISO 13485

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1. Purpose
The purpose of this document is to identify gaps to previous versions and show compliance to the applicable requirements of “EN ISO
11135:2014/AMD 1:2019”

2. Product in Scope
Ophthalmic Microsurgical Knives

3. Reference standards
EN ISO 11135:2014/AMD 1:2019 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine
control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release
EU MDR 2017/745 – European Union Medical device regulation
 EN ISO 11135:2014/AMD 1:2019- Gap Analyis

DIN EN ISO 13485

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4. Standard Compliance Checklist

Applicability/ Impact on
Standard Requirements Evidence
Rational Validation
ISO 11135:2014 vs ISO 11135:2014/AMD 1:2018

Summary of change
The amendment changes one of the Annexes in the standard - Annex E: Single Annex -E is not n.a n.a
batch release. This annex covers requirements for releasing product from a applicable as no
sterilization process that is not in routine production – for example, during design knives for
and development, including product for clinical investigation. This approach can design and
be applicable if a new product cannot be assigned to an existing family of development or
products for the purposes of sterilization validation. The approach can only be clinical
used to release product to market from multiple batches where the information investigation
from the single batch is part of a full validation protocol. are
manufactured
 EN ISO 11135:2014/AMD 1:2019- Gap Analyis

DIN EN ISO 13485

Page 3 of 3

Applicability/ Impact on
Standard Requirements Evidence
Rational Validation

ISO 11135:2014/AMD 1:2018 vs EN ISO 11135:2014/AMD 1:2019

Summary of change
The amendment makes changes to the Annex Zs which show the relationship Yes 6A List of n.a
between the standard and the Directives for active implantable medical EN ISO Applicable
devices, medical devices and in vitro diagnostic medical devices. Otherwise the 11135:2014/ Standards
content of EN ISO 11135:2014/AMD 1:2019 is identical to ISO 11135:2014/AMD AMD 1:2019 is
1:2018. now listed in the
Official Journal –
Regulation (EU)
2017/7451 of the
European
Parliament

Conclusion
The gap-analysis did not identify gaps of existing documentation to the new version EN ISO 11135:2014/AMD 1:2019. SURGI LAB demonstrated compliance of
existing documentation to EN ISO 11135:2014/AMD 1:2019.