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ISO 10524-1 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices
January 1, 2018 - ISO

This document specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures in the treatment, management, diagnostic evaluation and care of patients or for...

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...

DIN EN ISO 18082 - Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014 + Amd. 1:2017) (includes Amendment :2017)
December 1, 2017 - DIN

This International Standard specifies the dimensions, the allocation and marking of noninterchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute. This International...

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 II - JIS Medical Devices II Handbook
January 1, 2015 - JSA
A description is not available for this item.
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 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...

DIN EN ISO 10297 - Gas cylinders - Cylinder valves - Specification and type testing (ISO 10297:2014, Corrected Version 2014-11-01 + Amd.1:2017) (includes Amendment :2017)
December 1, 2017 - DIN

This International Standard specifies design, type testing and marking requirements for: a) cylinder valves intended to be fitted to refillable transportable gas cylinders; b) main valves (excluding ball valves) for cylinder bundles; c) cylinder valves or main valves with integrated pressure...

DS/EN 61010-2-101 - Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
February 27, 2017 - DS

IEC 61010-2-101:2015 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with...

ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws
March 1, 2017 - ASTM

This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws...

DEF STAN 81-41: PART 1 - Packaging of Defence Materiel Part: 1 : Introduction to Defence Packaging Requirements
December 14, 2016 - MODUK

This Part of the Defence Standard provides the package designer with information about the MOD requirement for packaging items of equipment and spares, defines the various types and levels of packaging used and outlines the requirements for packaging premises, transport, handling and storage...

UL 1795 - UL Standard for Safety Hydromassage Bathtubs
September 2, 2016 - UL

These requirements cover indoor hydromassage bathtubs, rated 250 volts or less, for household and commercial use, for permanent connection to the plumbing of the building. They are intended for either permanent connection to the electrical supply or are factory-provided with a cord terminating in...

DS/EN 62570 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
July 1, 2015 - DS

IEC 62570:2014 applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking....

DS/EN 61010-2-040 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
September 15, 2015 - DS

IEC 61010-2-040:2015 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. It has...

SNZ AS/NZS IEC 60601.2.1 - Medical electrical equipment - Part 2.1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
September 14, 2015 - SNZ

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for treatment of PATIENTS. This particular standard, with the inclusion of TYPE TESTS and SITE...

CEI EN 61331-2 - Protective devices against diagnostic medical X-radiation Part 2: Translucent protective plates
August 1, 2015 - CEI

This part of IEC 61331 applies to TRANSLUCENT PROTECTIVE PLATES used for RADIATION PROTECTION in X-ray diagnosis and in X-ray therapy. It also applies to TRANSLUCENT PROTECTIVE PLATES used for protection against GAMMA RADIATION in nuclear medicine and BRACHYTHERAPY with automatically-controlled...

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...

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