GB 12264-1990
Replaced
GB/T 30659-2014
Active
National standards
GB/T 30659-2014 External limb prostheses and external orthoses—Requirements and test methods
GB/T 30659-2014 External limb prostheses and external orthoses—Requirements and test methods
Basic Information
Standard Code:
GB/T 30659-2014
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2014-12-31
Implement Date:
2015-07-01
Pages:
76 pages
Scope
This standard sets out the requirements and test methods for prostheses and orthoses classified as follows by ISO 9999:
06 0306 15 Orthoses
06 1806 27 Prostheses
This standard includes provisions on strength, materials, usage restrictions, risks, and information related to the normal use conditions of components and component assemblies.
As special correction chair seats do not fall under the ISO 9999 classification of orthoses and are not intended for normal wear, this standard does not include special correction chair seats.
Development Information
Referenced Standards
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
ISO 8548-1
ISO 8548-2
ISO 8548-3
ISO 8549-1
ISO 8549-2
ISO 8549-3
ISO 10328
ISO 13404:2005
ISO 13405-1
ISO 13405-2
ISO 13405-3
ISO 15032
ISO 22675
IEC 60335-2-17
IEC 60601-1-2
IEC 61000-4-3
EN 1041
EN 50082-2
Adopt standards
ISO 22523:2006
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced