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GB/T 30659-2014 English PDF

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US$1534.00 · In stock
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GB/T 30659-2014: External limb prostheses and external orthoses -- Requirements and test methods
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 30659-2014	1534	Add to Cart	8 days	External limb prostheses and external orthoses -- Requirements and test methods	Valid

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Basic data

Standard ID: GB/T 30659-2014 (GB/T30659-2014)
Description (Translated English): External limb prostheses and external orthoses -- Requirements and test methods
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 77,726
Date of Issue: 12/31/2014
Date of Implementation: 7/1/2015
Quoted Standard: GB 9706.1-2007; GB/T 15721.1-2009; GB/T 15721.2-2009; GB/T 15721.3-2009; GB/T 14191.1-2009; ISO 8549-2; ISO 8549-3; ISO 10328; ISO 13404-2005; GB/T 17255.1-2009; GB/T 17255.2-2009; GB/T 17255.3-2009; GB/T 19543-2004; ISO 22675; GB 4706.8-2008; YY 0505-20
Adopted Standard: ISO 22523-2006, IDT
Regulation (derived from): National Standards Bulletin 2014 No. 33
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard specifies the requirements and test methods for prosthetics and orthotics of ISO 9999 classified as follows: 0603-0615 0618-0627 prosthetic orthotic This standard covers strength, materials, usage restrictions, risk and with components and c

GB/T 30659-2014: External limb prostheses and external orthoses -- Requirements and test methods

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
External limb prostheses and external orthoses - Requirements and test methods ICS 11.040.40 C35 National Standards of People's Republic of China Prosthetics and orthotics requirements and test methods (ISO 22523.2006, IDT) Issued on. 2014-12-31 2015-07-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Introduction Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 General requirements 4 4.1 Risk Management 4 4.2 Expected performance and technical documents 4 4.3 clinical assessment 4 4.4 intensity and associated conditions 5 5 5 Materials Requirements 5.1 Materials flammability and toxicity of combustion 5 5.2 biocompatibility and contaminants and residues 6 5.2.1 General 6 5.2.2 contaminants and residues 6 5.3 6 infection and microbial contamination 5.4 corrosion and degradation 6 Noise and vibration 6 6 7 6 Electromagnetic Compatibility 8 7 Electrical Safety 8.1 battery-powered prosthetics and orthotics 7 8.1.1 battery case and connector 7 8.1.2 Level Indicator 7 7 8.2 Circuit Protection 8.3 programmable electronic system 7 8.4 blankets, pads and similar flexible heating appliances 7 8.5 Skin contact electrodes 7 prosthetics and orthotics 8.6 is equipped with radio equipment prosthetics and orthotics 7 8.6.1 General 7 8.6.2 Spectrum radio equipment 8 8.6.3 user to operate radio equipment 8 9 8 Surface Temperature 10 Disinfection 8 11 design requirements 8 Security 11.1 movable member 8 11.2 joint security 8 12 Mechanical requirements 9 12.1 Limitations 9 12.2 pairs of human soft tissue force 9 Ergonomics 12.3 Principle 9 13 information supplied by the manufacturer 9 13.1 General 9 13.2 Label 10 13.3 Intended use 10 14 Packaging 10 Appendix A (informative) Prosthetic strength test Guide 11 (Normative) Mechanical Properties of the hinge assembly knee lower limb orthotics Appendix B Determination 24 Determination of flammability and toxicity of Annex C (informative) lower limb prosthesis combustion methodological guide 35 Annex D (informative) steering control prosthetics and orthotics and a drive mechanism to determine the force and torque required methodological guide 47 Appendix E (Informative Appendix) ISO /T R16142 basic principles of safety and performance of medical devices reference 69 References 71

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard uses the translation method identical with ISO 22523.2006 "prosthetics and orthotics requirements and test methods." Correspondence between the consistency of the standards of international documents and normative references of the following documents. --- GB 4706.8-2008 household and similar electrical appliances - Safety blankets, pads and similar flexible heating appliances special Requirements (IEC 60335-2-17.2006, IDT); --- GB/T 14191.1-2009 Prosthetics and orthotics academic language - Part 1. external limb prostheses and external orthoses Basic terms (ISO 8549-1. 1989, IDT); --- GB/T 15721.1-2009 Prosthetics and orthotics - Limb deficiencies - Part 1. congenital limb deficiencies described party Method (ISO 8548-1. 1989, IDT); --- GB/T 15721.2-2009 Prosthetics and orthotics - Limb deficiencies - Part 2. Method of describing lower limb amputation stumps (ISO 8548-2.1993, IDT); Method of describing upper limb amputation stumps. --- GB/T 15721.3-2009 Prosthetics and orthotics - Limb Part 3 missing (ISO 8548-3.1993, IDT); --- GB/T 17255.1-2009 Prosthetics and orthotics - Classification and description of prosthetic components - Part 1. Classification of prosthetic components (ISO 13405-1.1996, IDT); --- GB/T 17255.2-2009 Prosthetics and orthotics - Classification of prosthetic components and description Part 2. lower limb prosthetic components Description (ISO 13405-2.1996, IDT); --- GB/T 17255.3-2009 Prosthetics and orthotics - Classification of prosthetic components and description Part 3. upper limb prosthetic components Description (ISO 13405-3.1996, IDT); --- GB/T 17626.3-2006 Electromagnetic compatibility - Testing and measurement techniques RFEMS test (IEC 61000-4-3.2002, IDT); --- GB/T 19543-2004 prosthetic hip structure inspection (ISO 15032.2000, IDT); --- YY0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and Test (IEC 60601-1-2.2004, IDT). This standard made the following editorial changes. --- 4.4.4 in the second column item number repetitions of the letters "a)" to "b)", "b)" to "c)", "c)" to "d)"; --- D.6.4 Note the number "Note 5" to "Note 4." Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. The standard proposed by the People's Republic of China Ministry of Civil Affairs. This standard by the national rehabilitation and special equipment Standardization Technical Committee on Persons with Disabilities (SAC/TC148) centralized. This standard was drafted. national rehabilitation aids research center. The main drafters of this standard. Ma Feng collar, Liu Junling.

Introduction

This standard gives as medical equipment prosthetics and orthotics compliance with EU Directive 93/42 appendix/EEC 1 describes medical Basic treatment equipment required authentication method. This standard also gives radio equipment with 3.8 defined prosthetics and orthotics compliance with EU Directive 99/5/EC of the radio set Equipment and basic requirements for telecommunications terminal equipment authentication method. The standard authentication method meet other requirements of the Directive is not given. Aids standard score below three, a maximum. A. General requirements for assistive devices; Class 2. Particular requirements for the series of assistive devices; Three levels. the specific requirements of various types of assistive devices. If there are existing standards (two or three) for a particular class of auxiliary aids or devices, the lower-level standards take precedence over the more Grade standards. Therefore, when all the requirements set forth specific assistive devices, it is necessary to reference the existing minimum grade standards. This standard is secondary and tertiary (lowest level) combination of standard prosthetics and orthotics, see the range. This standard, in addition to the existing reference test standards, test methods for several types of prosthetics and orthotics also see Appendices A to D. respectively This standard relations with the EU Directive, see Appendix E. NOTE. Although this standard EN12181 standard level of the auxiliary appliance "aids - General requirements and test methods" are not mentioned, but it is recommended that the reference to standard. Prosthetics and orthotics requirements and test methods

1 Scope

This standard gives requirements and test methods of prosthetics and orthotics ISO 9999 classified as follows. 0603-0615 orthosis 0618-0627 prostheses This standard covers strength, materials, usage restrictions, risk and normal conditions of use and the related components and component assembly information. Due to special corrective seat does not belong to ISO 9999 and is a non-classified orthotics normal wearing article, this standard does not include special corrective seat. Note 1. This standard will be included in future the new orthopedic shoes (0633 classification). Note 2. The ISO 13485 and ISO 13488 quality system set forth or referred to are suitable.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988 A1.1991 A2. 1995, IDT) ISO 8548-1 Prosthetics and orthotics - Limb deficiencies - Part 1. congenital limb deficiencies described method (Prosthetics andorthotics-Limbdeficiencies-Part 1. Methodofdescribinglimbdeficienciespresentatbirth) ISO 8548-2 Prosthetics and orthotics - Limb deficiencies - Part 2. Method of describing lower limb amputation stumps (Prostheticsandor- thotics-Limbdeficiencies-Part 2. Methodofdescribinglowerlimbamputationstumps) ISO 8548-3 Prosthetics and orthotics - Limb deficiencies - Part 3. Method of describing upper limb amputation stumps (Prostheticsandor- thotics-Limbdeficiencies-Part 3. Methodofdescribingupper-limbamputationstumps) Basic terms external limb prostheses and external orthoses. ISO 8549-1 Prosthetics and orthotics academic language - Part 1 (Prostheticsandorthotics-Vocabulary-Part 1. Generaltermsforexternallimbprosthesesandex- ternalorthoses) ISO 8549-2 Prosthetics and orthotics academic language - Part 2. with prostheses and prosthetic wearer-related terminology (Prosthetics andorthotics-Vocabulary-Part 2. Termsrelatingtoexternallimbprosthesesandwearersofthese prostheses) ISO 8549-3 Prosthetics and orthotics academic language - Part 3. and orthotics related terms (Prostheticsandorthot- ics-Vocabulary-Part 3. Termsrelatingtoexternalorthoses) Structural inspection requirements ISO 10328 prosthetic lower limb prosthesis and test methods (Prosthetics-Structuraltestingof lower-limbprostheses-Requirementsandtestmethods) ISO 13404.2005 Prosthetics and orthotics orthotics and orthotic components classification and description (Prostheticsand orthotics-Classificationanddescriptionofexternalorthosesandorthoticcomponents) ISO 13405-1 Classification and description of prosthetic and orthotics prosthetic components - Part 1. Classification of prosthetic components (Prosthetics andorthotics-Classificationanddescriptionofprostheticcomponents-Part 1. Classificationofpros- theticcomponents) Description of lower limb prosthetic components (Pros-. ISO 13405-2 Classification and description of prosthetic and orthotic prosthetic components - Part 2 ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 30659-2014_English be delivered?

Answer: Upon your order, we will start to translate GB/T 30659-2014_English as soon as possible, and keep you informed of the progress. The lead time is typically 5 ~ 8 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 30659-2014_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 30659-2014_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.