ISO 20737 Certification Service

What is ISO 20737:2021?
ISO 20737:2021 is an international standard that specifies requirements and test methods for contact lens care products — particularly those used for cleaning, disinfecting, rinsing, and storing contact lenses. This standard ensures the microbiological safety, performance, and labeling of lens care products used by consumers, aligning with global safety and health regulations for eye care.

ISO 20737 – Overview
ISO 20737 is part of a group of standards developed for medical devices and products used in direct contact with the eye. It outlines the performance benchmarks for contact lens care solutions, including efficacy against microorganisms, physical compatibility with lenses, and instructions for safe usage. The standard is applicable to manufacturers of multipurpose solutions, hydrogen peroxide systems, and saline rinsing fluids, helping maintain user eye health by minimizing contamination risks and enhancing lens hygiene practices.

ISO 20737:2021 Key Requirements
Specifies microbiological performance criteria to ensure effective disinfection of contact lenses.
Outlines methods for testing antibacterial, antifungal, and anti-amoebic efficacy of solutions.
Mandates labeling instructions for use, storage conditions, expiration, and precautions.
Requires compatibility testing to verify that lens materials are not damaged by care products.
Establishes test protocols for inactivation of potential ocular pathogens during soaking.
Includes requirements for shelf life stability and packaging integrity to preserve sterility.
Applies to solutions used with soft, rigid gas permeable, and hybrid contact lenses.
Promotes proper hygiene, patient safety, and prevention of eye infections.

ISO 20737 Certification with Quality Asia Certification
Quality Asia Certification offers ISO 20737:2021 certification services to manufacturers of contact lens care products. Certification demonstrates that the product meets stringent safety and efficacy standards as defined by ISO for healthcare and consumer safety. It verifies product conformity in terms of microbiological control, lens compatibility, and user safety, ensuring that only high-quality and reliable products reach the market.

Certification Process for ISO 20737
Application Review – Evaluation of product type, intended use, and lens compatibility claims.
Stage 1 Audit – Review of test data for microbiological efficacy, material safety, and labeling accuracy.
Stage 2 Audit – On-site inspection of manufacturing practices, quality control systems, and documentation.
Certification Decision – Issuance of ISO 20737:2021 certificate upon verification of compliance.
Surveillance Audits – Ongoing monitoring to ensure continued adherence to quality and safety standards.
Recertification – Full compliance review conducted every three years to renew certification validity.

Benefits of ISO 20737 Certification
Ensures disinfection efficacy of lens care solutions to protect user eye health.
Confirms compatibility with a wide range of contact lens materials.
Builds consumer trust through reliable product safety and performance.
Supports global market access by meeting international regulatory expectations.
Reduces risk of eye infections and user complaints through proven testing.
Strengthens product quality reputation in the eye care and medical device industry.

Get ISO 20737 Certified with Us
If your organization manufactures contact lens care solutions, ISO 20737:2021 certification validates your product’s safety, microbiological effectiveness, and compatibility with lenses. Quality Asia Certification provides ISO certification services to help ensure your products meet global health and safety standards. Contact us today to begin your ISO 20737 certification process.