Medical Equipment Certification Standards

1.1 This part of IEC 60079 document , which is a technical specification Recommended Practice , specifies requirements for the design, construction, assembly, testing, inspection, marking, documenting and assessment of equipment assemblies for use in explosive atmospheres under the...

Abstract: Volumes 13.01 and 13.02 include over 380 standards on medical and surgical materials and devices. They cover metals, polymers, and ceramics for implants, prostheses, and medical and surgical devices; silicone elastomers, gels, and foams in medical applications; and...

Abstract: Volumes 13.01 and 13.02 include over 380 standards on medical and surgical materials and devices. They cover metals, polymers, and ceramics for implants, prostheses, and medical and surgical devices; silicone elastomers, gels, and foams in medical applications; and...

This document describes the technical recommendations for use of medical equipment in chronic HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles are important to be complied with to ensure safe, permissible and appropriate application. The term HAEMODIALYSIS is...

This document describes the technical recommendations for use of medical equipment in chronic HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles are important to be complied with to ensure safe, permissible and appropriate application. The term HAEMODIALYSIS is...

IEC TR 62653:2020 is available as IEC TR 62653:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC TR 62653:2020 describes the technical recommendations for use of medical...

This Protocol is intended to cover certification of drug testing sample collection and security equipment, including urine, whole blood, and serum blood sample collection, and encompasses required testing methods, design, and material requirements for this equipment. This...

This Model Code applies to the safety of medical electrical equipment (MEE) and medical electrical systems (MES) as it pertains to protection from electrical shock, and fire and mechanical hazards. It provides construction, marking, and test requirements for the field...

This part of IEC 60079, which is a technical specification, specifies requirements for the design, construction, assembly, testing, inspection, marking, documenting and assessment of equipment assemblies for use in explosive atmospheres under the responsibility of the manufacturer of the...

IEC TS 60079-46:2017(E) specifies requirements for the design, construction, assembly, testing, inspection, marking, documenting and assessment of equipment assemblies for use in explosive atmospheres under the responsibility of the manufacturer of the equipment assembly. The...

This part of IEC 60079, which is a technical specification, specifies requirements for the design, construction, assembly, testing, inspection, marking, documenting and assessment of equipment assemblies for use in explosive atmospheres under the responsibility of the manufacturer of the...