SIST EN ISO 25424:2020/A1:2022
(Amendment)Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
2022-01-13 - TC decision is missing to skip FV - publication on hold.
Sterilisation von Produkten für die Gesundheitsfürsorge - Niedertemperatur-Dampf-Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung von Sterilisationsverfahren für Medizinprodukte - Änderung 1 (ISO 25424:2018/Amd 1:2022)
No scope available
Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux - Amendement 1 (ISO 25424:2018/Amd 1:2022)
Sterilizacija izdelkov za zdravstveno nego - Para z nizko temperaturo in s formaldehidom - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke - Dopolnilo A1 (ISO 25424:2018/Amd 1:2022)
General Information
Relations
Overview
EN ISO 25424:2019/A1:2022 is the CEN-endorsed amendment to ISO 25424, addressing sterilization of health care products using low temperature steam and formaldehyde. The amendment updates requirements for the development, validation and routine control of sterilization processes for medical devices. It clarifies the scope of application, links to EU medical device regulations, and references key microbiological, biological and chemical indicator standards used in process qualification and routine monitoring.
Note: users should confirm the current publication/endorsement status with their national standards body or the CEN website.
Key topics and technical requirements
- Process development and validation: requirements for designing and validating a low-temperature steam/formaldehyde sterilization cycle so that treated devices are safe and perform as intended after sterilization.
- Routine control and monitoring: expectations for cycle monitoring, use of biological and chemical indicators, and ongoing control to demonstrate continued process performance.
- Microbiological considerations: alignment with microbiological methods and sterility test principles (references include ISO 11737‑1 and ISO 11737‑2) for establishing microbial load and sterility test protocols.
- Indicators and acceptance criteria: normative linkage to biological indicator standards (ISO 11138 parts) and chemical indicators (ISO 11140‑1) for process qualification and routine checks.
- Regulatory alignment and risk management: annexes explain how the standard supports conformity to EU Regulations 2017/745 (medical devices) and 2017/746 (IVDs). Risk management references must be consistent with those Regulations.
- Limitations: the standard focuses on attainment of a specific microbial state by low temperature steam and formaldehyde; it does not cover device packaging design for maintenance of sterility during transport/storage or unrelated manufacturing aspects.
Applications and who uses it
- Medical device manufacturers performing sterilization process development and validation for devices sensitive to higher‑temperature methods.
- Sterile processing departments, contract sterilization service providers and validation engineers setting up or auditing low‑temperature steam & formaldehyde cycles.
- Quality assurance, regulatory affairs and compliance teams demonstrating conformity with EU General Safety and Performance Requirements.
- Test laboratories and indicator manufacturers implementing and interpreting biological and chemical indicator results for process qualification.
Related standards (normative references)
- ISO 11138‑1, ISO 11138‑5 - Biological indicators
- ISO 11140‑1 - Chemical indicators
- ISO 11737‑1, ISO 11737‑2 - Microbiological methods and sterility testing
EN ISO 25424:2019/A1:2022 is essential guidance for stakeholders involved in validation and routine control of low‑temperature steam/formaldehyde sterilization, helping ensure safe, reproducible sterilization of temperature‑sensitive medical devices.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2022
Sterilizacija izdelkov za zdravstveno nego - Para z nizko temperaturo in s
formaldehidom - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih
postopkov za medicinske pripomočke - Dopolnilo A1 (ISO 25424:2018/Amd 1:2022)
Sterilization of health care products - Low temperature steam and formaldehyde -
Requirements for development, validation and routine control of a sterilization process
for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
Sterilisation von Produkten für die Gesundheitsfürsorge - Niedertemperatur-Dampf-
Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung
von Sterilisationsverfahren für Medizinprodukte - Änderung 1 (ISO 25424:2018/Amd
1:2022)
Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température -
Exigences pour le développement, la validation et le contrôle de routine d'un procédé de
stérilisation pour dispositifs médicaux - Amendement 1 (ISO 25424:2018/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 25424:2019/A1:2022
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 25424:2019/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.080.01
English Version
Sterilization of health care products - Low temperature
steam and formaldehyde - Requirements for development,
validation and routine control of a sterilization process for
medical devices - Amendment 1 (ISO 25424:2018/Amd
1:2022)
Stérilisation des produits de santé - Formaldéhyde et Sterilisation von Produkten für die
vapeur à faible température - Exigences pour le Gesundheitsfürsorge - Niedertemperatur-Dampf-
développement, la validation et le contrôle de routine Formaldehyd - Anforderungen an die Entwicklung,
d'un procédé de stérilisation pour dispositifs médicaux Validierung und Routineüberwachung von
- Amendement 1 (ISO 25424:2018/Amd 1:2022) Sterilisationsverfahren für Medizinprodukte -
Änderung 1 (ISO 25424:2018/Amd 1:2022)
This amendment A1 modifies the European Standard EN ISO 25424:2019; it was approved by CEN on 28 December 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25424:2019/A1:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 8
European foreword
This document (EN ISO 25424:2019/A1:2022) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204
“Sterilization of medical devices” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 25424:2019 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by November 2022,
and conflicting national standards shall be withdrawn at the latest by November 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For the relationship with EU Regulation(s) see informative Annex ZA and ZB, which are integral parts of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
The following referenced documents are indispensable for the application of this document. For
undated references, the edition of the referenced document (including any amendments) listed below
applies. For dated references, only the edition cited applies. However, for any use of this standard
within the meaning of Annex ZA and ZB the user should always check that any referenced document has
not been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed in table ZA.2.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 25424:2018/Amd 1:2022 has been approved by CEN as EN ISO 25424:2019/A1:2022
without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request M/575 to
provide one voluntary means of conforming to the General Safety and Performance Requirements of
Regulation (EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117] and to system or
process requirements including those relating to quality management systems, risk management, post-
market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-
up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation
(EU) 2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard
in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail. In this context, the definition of ‘medical device’ in EN ISO 25424 is a modified
version of the definition prepared by the Global Harmonization Task Force with modification to the
Note in the definition.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.
NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 – Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117]
General Safety and Performance
Clause(s) / sub-clause(s)
Requirements of Regulation Remarks / Notes
of this EN
(EU) 2017/745
11.3 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using low temperature
steam and formaldehyde for
medical devices, including
requirements that the medical
device is safe and performs as
intended after treatment. It could
also be applied to the
development, validation and
routine control of a process for
attainment of a specific microbial
state other than sterility. This
General Safety and Performance
Requirement is addressed only
with regard to devices for which
treatment by low temperature
steam and formaldehyde is
appropriate.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging
for maintenance of a specific
microbial state during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
attainment of a specific microbial
state by low temperature steam
and formaldehyde are not
covered.
11.4 first sentence only 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using low temperature
steam and formaldehyde for
medical devices, including
requirements that the sterilized
medical device is safe and
performs as intended after
sterilization. This General Safety
and Performance Requirement is
addressed only with regard to
devices for which sterilization by
low temperature steam and
formaldehyde is appropriate.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
attainment of sterility by low
temperature steam and
formaldehyde are not covered.
Evidence that the integrity of the
packaging is maintained to the
point of use is not covered.
11.5 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using low temperature
steam and formaldehyde for
medical devices, including
requirements that the sterilized
medical device is safe and
performs as intended after
sterilization. This General Safety
and Performance Requirement is
addressed only with regard to
devices for which sterilization by
low temperature steam and
formaldehyde is appropriate.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Packaging for
maintenance of sterility is not
covered. Aspects of manufacture
other than those related to
attainment of sterility by low
temperature steam and
formaldehyde are not covered.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Reference Column 2 Column 3 Column 4
in Clause 2 International
Title Corresponding European
...
Frequently Asked Questions
SIST EN ISO 25424:2020/A1:2022 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)". This standard covers: 2022-01-13 - TC decision is missing to skip FV - publication on hold.
2022-01-13 - TC decision is missing to skip FV - publication on hold.
SIST EN ISO 25424:2020/A1:2022 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 25424:2020/A1:2022 has the following relationships with other standards: It is inter standard links to SIST EN ISO 25424:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 25424:2020/A1:2022 is associated with the following European legislation: EU Directives/Regulations: 2017/745, 2017/746; Standardization Mandates: M/575, M/575 AMD 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN ISO 25424:2020/A1:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
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