ISO 16671-2025 PDF
Name in English:
St ISO 16671-2025
Name in Russian:
Ст ISO 16671-2025
Original standard ISO 16671-2025 in PDF full version. Additional info + preview on request
Full title and description
St ISO 16671-2025 — Ophthalmic implants — Irrigating solutions for ophthalmic surgery. This international standard specifies safety and performance requirements, design attributes, preclinical and clinical evaluation, sterilization, packaging, labelling and the information to be supplied by the manufacturer for ophthalmic irrigating solutions used during ophthalmic surgery.
Abstract
ISO 16671:2025 defines requirements to ensure the safety of ophthalmic irrigating solutions (OIS) when used in ophthalmic surgical procedures. It covers intended performance, design characteristics, required preclinical and clinical data, sterilization and packaging considerations, and labelling and supplier information. The solutions covered do not provide primary immunological, pharmacological or metabolic functions.
General information
- Status: Published (International Standard).
- Publication date: 12 June 2025.
- Publisher: International Organization for Standardization (ISO).
- ICS / categories: 11.040.70 (Ophthalmic equipment).
- Edition / version: Edition 3 (2025).
- Number of pages: 26–27 pages (varies by format/reporting).
Scope
This standard applies to ophthalmic irrigating solutions used during ophthalmic surgery. It does not apply to solutions whose primary function is immunological, pharmacological or metabolic. The standard sets out requirements for the safety and intended performance of these solutions and specifies the information manufacturers must supply to support safe use in surgical contexts.
Key topics and requirements
- Definition and classification of ophthalmic irrigating solutions and their intended use in ophthalmic surgery.
- Design attributes and materials considerations to ensure biocompatibility and functional safety.
- Preclinical evaluation requirements (bench testing, compatibility, sterility assessment).
- Clinical evaluation expectations and evidence to demonstrate safety for intended performance.
- Sterilization processes and validation specific to ophthalmic surgical use.
- Packaging, storage and transport requirements to preserve sterility and performance.
- Labelling, symbols and the information the manufacturer must supply to users and health professionals.
Typical use and users
Intended users include medical device manufacturers of ophthalmic irrigating solutions, regulatory affairs professionals preparing submission dossiers, clinical engineers and ophthalmic surgeons evaluating products for surgical use, and quality/sterility assurance teams. Typical applications are intraoperative irrigation during cataract, vitreoretinal and other ophthalmic procedures.
Related standards
ISO 16671:2025 revises and replaces ISO 16671:2015 (and its 2017 amendment). It is developed under ISO/TC 172/SC 7 (ophthalmic equipment) and is related to other ophthalmic device and medical device standards addressing sterility, biocompatibility and clinical evaluation.
Keywords
ophthalmic irrigating solution, OIS, ophthalmic implants, irrigating solution, ophthalmic surgery, sterility, labelling, clinical evaluation, biocompatibility, ISO 16671.
FAQ
Q: What is this standard?
A: ISO 16671:2025 is an international standard that specifies safety, performance and information requirements for ophthalmic irrigating solutions used in ophthalmic surgery.
Q: What does it cover?
A: It covers intended performance, design attributes, preclinical and clinical evaluation, sterilization and packaging, labelling, and the information manufacturers must supply for ophthalmic irrigating solutions; it excludes solutions with primary immunological, pharmacological or metabolic functions.
Q: Who typically uses it?
A: Manufacturers, regulatory and quality professionals, clinical engineers, hospital procurement teams and ophthalmic surgeons reference the standard when designing, assessing, procuring or using ophthalmic irrigating solutions.
Q: Is it current or superseded?
A: Current — ISO 16671:2025 (Edition 3) is the published replacement for ISO 16671:2015 and its 2017 amendment.
Q: Is it part of a series?
A: It is part of the body of ISO standards for ophthalmic equipment developed by ISO/TC 172/SC 7; while not numbered as a multi‑part series itself, it is closely related to other ISO standards covering ophthalmic implants, device sterility, biocompatibility and clinical evaluation.
Q: What are the key keywords?
A: Ophthalmic irrigating solution, OIS, ophthalmic surgery, implants, sterilization, labelling, clinical evaluation, biocompatibility, ISO 16671.