Medical Device Testing

EC/EN 60601-1:

General requirements for basic safety and essential performance

IEC/EN 60601-1-6:

General requirements for basic safety and essential performance - Collateral standard: Usability

IEC/EN 60601-1-11:

General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC/EN 60601-2-22:

applies to the Basic Safety and Essential Performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as Laser Product of Class 1C where the Enclosed Laser is of Class 3B or 4, or Class 3B, or Class 4. Medical Electrical Equipment or Medical Electrical Systems which incorporate lasers as sources of energy being transferred to the Patient or animal and where the lasers are specified as above, are referred to as “laser equipment” in this document.

ASTM D4169 & ISTA:

ASTM-D4169 describes the standard practice for performance testing of shipping containers and systems. It provides a guide for the evaluation of shipping units in accordance with a uniform system, using established test methods at levels representative of those occurring in actual distribution. The recommended test levels are based on available information on the shipping and handling environment, and current industry/government practice and experience.

ISTA, the International Safe Transit Association, is a nonprofit organization specific to concerns of transport packaging. ISTA is the leading industry developer of testing protocols and design standards that define how packages should perform to assure protection of their contents during the ever changing risks of the global distribution environment. It sets the standards for optimizing the resources in packages designed to be survivable, sustainable, and successful and to enhance the effectiveness of package design and testing.

ASTM F1980-16:

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

EN 14683:

EN 14683 is a standard that medical face masks in Europe are required to comply with. The testing requirements for this standard include bacterial filtration efficiency, differential pressure (breathability), splash resistance and microbial cleanliness.

ASTM F2100-19:

This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.