DIN EN ISO 16671 2015-12 PDF

Full title and description

DIN EN ISO 16671:2015-12 — Ophthalmic implants — Irrigating solutions for ophthalmic surgery. This is the German/adopted version of ISO 16671:2015 (with later amendment ISO 16671:2015/Amd 1:2017) and specifies safety, design, preclinical and clinical evaluation, sterilization, packaging, labelling and manufacturer information requirements for ophthalmic irrigating solutions used during ophthalmic surgery.

Abstract

ISO/DIN EN ISO 16671:2015 sets out requirements to ensure the safety and performance of ophthalmic irrigating solutions (OIS) used during ophthalmic procedures. It covers intended performance, product design attributes, preclinical and clinical evaluation, sterilization and microbiological aspects, packaging and labelling, and the information to be supplied by the manufacturer. An amendment was published in 2017; the ISO series was later updated with a 2025 edition.

General information

• Status: Superseded / withdrawn in later international revision (national DIN edition marked as superseded).
• Publication date: ISO main edition published August 2015; German adoption (DIN EN ISO 16671:2015-12) published in late 2015 (decimal month indicator "-12" denotes December national publication).
• Publisher: Deutsches Institut für Normung (DIN) — published as DIN EN ISO; original international publisher ISO.
• ICS / categories: 11.040.70 (Ophthalmic equipment / ophthalmic implants and solutions).
• Edition / version: Edition 2 (ISO 16671:2015) with amendment ISO 16671:2015/Amd 1:2017; national DIN adoption as DIN EN ISO 16671:2015-12.
• Number of pages: National/DIN publication: 33 pages (DIN listing); ISO edition listing indicates 22 pages for the ISO publication.

Scope

This standard applies to ophthalmic irrigating solutions (OIS) intended for use during ophthalmic surgery. It does not apply to products whose primary function is pharmacological, immunological or metabolic. The scope includes requirements for safety and performance, design attributes, biocompatibility and preclinical testing, clinical evaluation where applicable, sterilization methods and validation, packaging integrity, labelling content and the information supplied by the manufacturer to ensure safe and effective use in surgical settings.

Key topics and requirements

• Definition and classification of ophthalmic irrigating solutions and intended use statements.
• Design and formulation requirements to ensure compatibility with ocular tissues and surgical procedures.
• Preclinical evaluation: chemical, physical and biological testing, including biocompatibility and sterility-related testing.
• Clinical evaluation and evidence expectations where required to demonstrate safety and performance.
• Sterilization requirements and validation, including acceptable sterilization methods and packaging considerations to maintain sterility.
• Packaging, labelling and information supplied: content, warnings, storage, shelf life and traceability.
• Post-market considerations and need for vigilance/reporting of adverse events related to OIS.

Typical use and users

Used by manufacturers and regulatory/compliance teams that develop, test and market ophthalmic irrigating solutions; by quality, sterilization and packaging engineers; by clinical affairs and regulatory specialists preparing technical documentation and clinical evaluation reports; and by hospitals/ophthalmic surgical departments that require labelling, instructions for use and product information to support safe intraoperative use. Also used by national standards bodies and notified bodies assessing conformity.

Related standards

Related documents include the ISO series for ophthalmic instruments and implants (for example ISO 15004 series on ophthalmic instruments), other ISO guidance on medical device sterilization and packaging, and national/adopted EN versions. The 2015 edition has a published amendment (2017) and has later been revised by a 2025 ISO edition. Users should consult relevant complementary standards for testing methods, packaging, sterility assurance and clinical evaluation.

Keywords

ophthalmic irrigating solution; OIS; ophthalmic implants; ophthalmic surgery; sterilization; biocompatibility; packaging; labelling; clinical evaluation; DIN EN ISO 16671; ISO 16671:2015.

FAQ

Q: What is this standard?

A: A harmonised technical standard specifying safety, design, testing, sterilization, packaging and labelling requirements for ophthalmic irrigating solutions used during eye surgery; published internationally as ISO 16671:2015 and adopted nationally as DIN EN ISO 16671:2015-12.

Q: What does it cover?

A: It covers intended performance, product design attributes, preclinical and clinical evaluation needs, sterilization and packaging validation, labelling content and manufacturer-supplied information necessary to ensure safe and effective intraoperative use of OIS. It excludes products whose primary function is pharmacological, immunological or metabolic.

Q: Who typically uses it?

A: Manufacturers of ophthalmic irrigating solutions, regulatory and clinical affairs teams, quality/sterilization/packaging engineers, notified bodies and testing laboratories, and clinical end-users in ophthalmic surgery settings.

Q: Is it current or superseded?

A: The 2015 edition (with its 2017 amendment) has been superseded in the ISO lifecycle — ISO lists a newer edition published in 2025; national/DIN records also show the 2015 national adoption as superseded by later national editions. Users needing the current requirements should reference the latest ISO/DIN edition (check the 2025 international revision or the current DIN adoption).

Q: Is it part of a series?

A: It is part of the ophthalmic equipment/ophthalmic implants family of standards (ICS 11.040.70) and relates to other ISO/EN documents covering ophthalmic instruments, sterilization, packaging and clinical evaluation guidance. The document has an amendment record (2017) and sits within the ISO/TC 172/SC 7 technical committee work.

Q: What are the key keywords?

A: Ophthalmic irrigating solution; OIS; ophthalmic surgery; ophthalmic implants; sterilization; biocompatibility; packaging; labelling; clinical evaluation; DIN EN ISO 16671.