ISO 16671-2015 amd1-2017 PDF

Full title and description

ISO 16671:2015/Amd 1:2017 — Ophthalmic implants — Irrigating solutions for ophthalmic surgery — Amendment 1 (amendment to ISO 16671:2015). This amendment updates the 2015 International Standard that specifies safety, performance and information requirements for solutions used to irrigate the eye during ophthalmic surgical procedures.

Abstract

The amendment supplements ISO 16671:2015, which defines requirements regarding safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, labelling and the information supplied by the manufacturer for ophthalmic irrigating solutions (OIS). OIS are used during ophthalmic surgery and do not provide any primary immunological, pharmacological or metabolic function. The amendment provides specific editorial and technical changes intended to clarify and refine the original 2015 requirements.

General information

• Status: Withdrawn (replaced by ISO 16671:2025).
• Publication date: Amendment published October 2017 (ISO 16671:2015 published August 2015; replacement ISO 16671:2025 published June 2025).
• Publisher: International Organization for Standardization (ISO); adopted in various national/ regional catalogues as EN/ national standards.
• ICS / categories: 11.040.70 — Ophthalmic equipment.
• Edition / version: Amendment 1 to ISO 16671:2015 (Edition 2, 2015; amendment issued 2017).
• Number of pages: 1 (ISO amendment document — note: national or harmonized adopters sometimes publish longer derivative documents, typically 3–8 pages).

Scope

This amendment applies to ISO 16671:2015 and is limited to clarifications and technical adjustments to the requirements for ophthalmic irrigating solutions used during ophthalmic surgery. The underlying standard addresses safety and performance characteristics, required evaluations (preclinical/clinical), sterilization and packaging requirements, labelling content, and manufacturer-supplied information necessary to ensure safe use of irrigating solutions in ocular surgical settings.

Key topics and requirements

• Clarifications to definitions and terminology specific to ophthalmic irrigating solutions.
• Refinements to requirements for product information and labelling provided to users and clinicians.
• Adjustments to sterility/sterilization handling, validation and marking instructions where applicable.
• Updates to recommended preclinical and clinical evaluation practices related to ocular safety.
• Editorial corrections and harmonization with relevant normative references.

Typical use and users

Used by medical device manufacturers, product designers, regulatory affairs professionals, quality managers, clinical evaluators, and hospitals/ophthalmic surgical teams. The amendment is relevant when developing, documenting, testing, labelling and registering ophthalmic irrigating solutions for use in cataract, vitreoretinal and other intraocular procedures.

Related standards

ISO 16671:2015 (base standard), ISO 16671:2025 (replacement/revised edition); related medical device and biocompatibility standards commonly referenced alongside ISO 16671 include ISO 10993 series (biological evaluation of medical devices), ISO 11135 (ethylene oxide sterilization requirements) and applicable regional EN/adoption documents (EN ISO 16671 and national implementations).

Keywords

ophthalmic irrigating solutions, OIS, ophthalmic implants, irrigating solution, eye surgery, ophthalmic surgery, sterilization, labelling, preclinical evaluation, clinical evaluation, ISO 16671, amendment 2017

FAQ

Q: What is this standard?

A: It is Amendment 1 (2017) to ISO 16671:2015, which deals with requirements for irrigating solutions used during ophthalmic surgery — covering safety, performance, evaluation and information supplied by the manufacturer.

Q: What does it cover?

A: The amendment provides clarifications and specific adjustments to the 2015 standard's provisions on definitions, labelling, packaging, sterilization considerations and preclinical/clinical evaluation guidance for ophthalmic irrigating solutions.

Q: Who typically uses it?

A: Device manufacturers, R&D and regulatory teams, quality and clinical evaluation professionals, procurement teams in hospitals and ophthalmic surgeons/clinical staff involved in device selection and safe use.

Q: Is it current or superseded?

A: The amendment itself is withdrawn as the ISO 16671 family was revised and replaced by ISO 16671:2025. The 2015 edition and its 2017 amendment were superseded when the new consolidated 2025 edition was published (June 2025) and national adoptions took effect in mid-2025.

Q: Is it part of a series?

A: It is part of the ISO technical work on ophthalmic implants and ophthalmic equipment (ISO/TC 172/SC 7). Users commonly apply it together with related ISO standards on biological evaluation and sterilization (for example the ISO 10993 series and ISO 11135) and with regional EN/adopted copies.

Q: What are the key keywords?

A: Ophthalmic irrigating solution, OIS, ophthalmic implants, irrigating solutions for ophthalmic surgery, sterilization, labelling, preclinical evaluation, clinical evaluation, ISO 16671, amendment 2017.