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NEMA EL P1 - NEMA Position Paper on Electronic Labeling
January 1, 2018 - NEMA

Introduction Although the objective of this white paper is to communicate the NEMA position on the concept of electronic labeling, introductory remarks on the historical need for electrical equipment and medical device labeling could enhance understanding of how electronic labeling...

DS/IEC TS 60079-46 - Explosive atmospheres – Part 46: Equipment assemblies
September 4, 2017 - DS

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...

JIS MEDICAL DEVICES IV - JIS Medical Devices IV Handbook
January 1, 2015 - JSA
A description is not available for this item.
JIS MEDICAL DEVICES I - JIS Medical Devices I Handbook
January 1, 2015 - JSA
A description is not available for this item.
JIS MEDICAL DEVICES II - JIS Medical Devices II Handbook
January 1, 2015 - JSA
A description is not available for this item.
JIS MEDICAL DEVICES III - JIS Medical Devices III Handbook
January 1, 2015 - JSA
A description is not available for this item.
IEC TS 60079-46 - Explosive atmospheres – Part 46: Equipment assemblies
August 1, 2017 - IEC

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...

ASSE SERIES 6000 - Professional Qualifications Standard for Medical Gas Systems Personnel – Medical Gas Systems Generalists – Medical Gas Systems Installers – Bulk Medical Gas Systems Installers – Medical Gas Systems Inspectors – Medical Gas Systems Verifiers – Bulk Medical Gas Systems Verifiers – Medical Gas Systems Maintenance Personnel – Medical Gas Systems Instructors – Bulk Medical Gas Systems Instructors
July 1, 2015 - ASSE

FOREWORD This foreword shall not be considered a part of the standard. However, it is offered to provide background information. ASSE International, formerly known as the American Society of Sanitary Engineering, is dedicated to the preservation of public health and safety through "Prevention...

CSA SPE-3000 - Model Code for the field evaluation of medical electrical equipment and systems
January 1, 2015 - CSA

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

CEI 62-236 - Medical plantar pressure measurement devices (PPMDs): Measuring performance
January 1, 2015 - CEI

This Standard deals with the technical assessment of the measuring performance of the medical PPMD (classified by the Manufacturer to be an active MD with measuring function), and the maintenance of the quality of measuring performance during its lifetime. The Standard is addressed to: ●...

CSA SPE-1000 - Model Code for the field evaluation of electrical equipment
May 1, 2013 - CSA

This Model Code provides marking and test/construction requirements for the field evaluation of electrical equipment by an inspection body, where certification of that equipment is impracticable or otherwise unavailable. Field-evaluated equipment found to be in...

DS/IEC/TR 62653 - Guideline for safe operation of medical equipment used for haemodialysis treatments
September 12, 2012 - DS

This technical report describes the technical requirements for use of equipment in HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles should be complied with to ensure safe, permissible and proper application. The physician is responsible for the HAEMODIALYSIS treatment...

IEC/TR 62653 - Guideline for safe operation of medical equipment used for haemodialysis treatments
June 1, 2012 - IEC

This technical report describes the technical requirements for use of equipment in HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles should be complied with to ensure safe, permissible and proper application. The physician is responsible for the HAEMODIALYSIS treatment...

IEC/TR 80001-2-2 - Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
July 1, 2012 - IEC

This part of IEC 80001 creates a framework for the disclosure of security-related capabilities and RISKS necessary for managing the RISK in connecting MEDICAL DEVICES to IT-NETWORKS and for the security dialog that surrounds the IEC 80001-1 RISK MANAGEMENT of IT-NETWORK connection. This...

AAMI TIR80001-2-2 - Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
January 1, 2012 - AAMI

This part of IEC 80001 creates a framework for the disclosure of security-related capabilities and RISKS necessary for managing the RISK in connecting MEDICAL DEVICES to IT-NETWORKS and for the security dialog that surrounds the IEC 80001-1 RISK MANAGEMENT of IT-NETWORK connection. This...

ISO 14000 CERTIFICATION - REFER TO ISO ISBN 92-67-10278-8
ISO
A description is not available for this item.
ISO 9000 CERTIFICATION - REFER TO ISO ISBN 92-67-10278-8
ISO
A description is not available for this item.
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