ISO 11137-1 Second edition 2025-04 — FDA recognition transition and report handoff
FDA’s acquired supplementary sheets explicitly connect 14-528 to 14-611 and state declaration-acceptance date(s) for the replaced recognition: recognition 14-528: 2027-07-04. Compare the exact edition and recognition limitations with your reports before agreeing the submission evidence or further work.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Exact FDA recognition records
Compare the edition and the recognized portion
Read these columns together. A complete recognition is not a device-specific testing instruction. The limitations are the FDA’s public metadata; the licensed standard itself is not reproduced.
Recognition / edition
Public recognition limitations
Declaration transition context
FDA 14-528 ISO 11137-1 First edition 2006-04-15; ANSI AAMI ISO 11137-1:2006/(R)2015
Sterilization of health care products - Radiation - Part 1: Requirements for development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]; Sterilization of health care products - Radiation - Part 1: Requirements for development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
Sterilization of health care products - Radiation - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices
Declaration transition contextNo expiration date is stated in this acquired export row. That is not a guarantee of indefinite recognition.
What FDA’s transition statement says
Recognition 14-528 → 14-611
FDA recognition of ISO 11137-1 First edition 2006-04-15 [Rec# 14-528] will be superseded by recognition of ISO 11137-1 Second edition 2025-04 [Rec# 14-611]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-528] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 14-528] will not be accepted.
Exact statements were reconciled on both acquired sheets and against the old recognition’s exported date. [1][2]
FDA public recognition metadata describes use of declarations of conformity in support of premarket submissions. A recognition transition is not a universal retesting deadline, a product ban, or proof that this standard applies to your device. The technical differences between licensed editions, adequacy of existing reports, buyer-specific route and final test scope remain incomplete. The comparison below does not reproduce the standard or establish FDA approval.
Method: Exact directed old-to-new statements are reconciled across both acquired sheets and the old export date. No name-similarity mapping or technical-clause inference.
Build your edition-to-report handoff matrix
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Which edition is actually in your evidence?
Reconcile each report and declaration against ISO 11137-1 Second edition 2025-04 and the replaced designation(s) ISO 11137-1 First edition 2006-04-15; ANSI AAMI ISO 11137-1:2006/(R)2015. Record amendments and the exact report/device revision. A similar standard number is not an edition match.
Does the declaration cover the recognized portion?
Use the complete FDA public limitation text in the comparison table. Map each listed exclusion, where present, to the relevant report sections and obtain a reasoned evidence assessment. Complete recognition still does not determine device applicability.
Useful evidence: Recognition-to-report coverage matrix, excluded-clause assessment and the licensed edition used by your specialist.
How does the recorded transition affect your submission plan?
Record planned declaration/submission dates against the FDA sheet’s acceptance date(s): recognition 14-528: 2027-07-04. This concerns declarations supporting premarket submissions to the replaced recognition; do not treat it as a blanket deadline to retest or stop selling.
Useful evidence: Submission plan, intended declaration references, dated recognition-sheet check and rationale for the chosen evidence route.
What changed beyond the designation?
Ask the specialist to assess the actual licensed edition/amendment differences for your design, materials, software and use environment. Separate a documented evidence gap from a changed title. This metadata comparison does not establish which tests changed or must be repeated.
Useful evidence: Edition gap assessment tied to the device and existing evidence, with a bridging rationale and unresolved inputs.
What should the quote include?
Request a report/recognition reconciliation and a justified gap assessment first. Separate any proposed additional evaluation or testing, samples, methods, deliverables and exclusions; agree them only after applicability and existing evidence are assessed.
Useful evidence: A scoped evidence-assessment quote; separately identified conditional work and report ownership.
Work packages and dependencies
Conditional: FDA submission evidence and declaration review — Assess exact recognition references, submission timing, existing reports and the rationale for any evidence gaps for ISO 11137-1 Second edition 2025-04. No predicate or device route is determined here.
Conditional: Sterilization + Microbiology Validation — Assess existing evidence and the specific public recognition limitations before proposing additional work. Specialty grouping is a discovery aid, not proof that a test or provider capability applies.
What needs to happen first
Sterilization + Microbiology Validation → FDA 510(k) Submission Services: If the evidence assessment identifies additional work needed for the agreed submission scope.
Questions for providers
Which of our reports actually cite ISO 11137-1 Second edition 2025-04, and which cite the replaced edition(s)?
How do the exact FDA recognition limitations affect the evidence you propose to reference?
What documented technical differences justify bridging evidence or additional work for our device?
How does our planned submission and declaration route relate to the acceptance date(s) recognition 14-528: 2027-07-04?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
