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GB/T 29791.5-2013 English PDF

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US$214.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 29791.5-2013: In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 29791.5-2013	214	Add to Cart	3 days	In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing	Valid

Similar standards

GB/T 29791.3 GB/T 26124 GB/T 21415 GB 19083 GB/T 29791.4 GB/T 29791.1

Basic data

Standard ID: GB/T 29791.5-2013 (GB/T29791.5-2013)
Description (Translated English): In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 11,191
Quoted Standard: ISO 14971; ISO 15223-1; ISO 18113-1; IEC 61010-1; IEC 61010-2-101; IEC 61326-2-6; IEC 62366; EN 980
Adopted Standard: ISO 18113-5-2009, IDT
Regulation (derived from): National Standards Bulletin No. 21 of 2013
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 self-test in vitro diagnostic (IVD) equipment manufacturers to provide information on request. This standard also applies to devices and equipment is expected and in vitro diagnostic medical devices for self use with. This stan

GB/T 29791.5-2013: In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing

---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.
. In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 5.. In vitro diagnostic instrumnets for selftesting ICS 11.100 C44 National Standards of People's Republic of China In vitro diagnostic medical devices Information supplied by the manufacturer (labeling) Part 5. In vitro diagnostic instruments for self Informationsuppliedbythemanufacturer (labeling) - Part 5. Invitrodiagnosticinstrumentsforselftesting (ISO 18113-5.2009, IDT) Issued on. 2013-10-10 2014-02-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Foreword

GB/T 29791 "in vitro diagnostic medical devices - Information supplied by the manufacturer (labeling)" is divided into five parts. --- Part 1. Terms, definitions and general requirements; --- Part 2. In vitro diagnostic reagents for professional use; --- Part 3. In vitro diagnostic instruments for professional use; --- Part 4. In vitro diagnostic reagents for self; --- Part 5. In vitro diagnostic instruments for self. This section GB/T 29791 Part 5. This section drafted in accordance with GB/T 1.1-2009 given rules. This section uses the translation method identical with ISO 18113-5.2009 "in vitro diagnostic medical device manufacturers to provide information (labeling) Article Part 5. In vitro diagnostic instruments for self. " Consistency correspondence between this part of international documents and normative references of our files are as follows. --- YY/T 0316-2008 medical device risk management to medical devices applications (ISO 14971.2008, IDT) Symbols - Part 1 --- YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information provided. pass With requirements (ISO 15223-1.2007, IDT) --- GB 4793.1-2007 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements (IEC 61010-1.2001, IDT) --- YY0648-2008 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101. In vitro diagnostic (IVD) requirements for medical equipment (IEC 61010-2-101.2002, IDT) 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. This part is proposed by the State Food and Drug Administration. This part of the National Medical clinical testing laboratory and in-vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This section is drafted. Beijing Medical Device Testing. The main drafters of this section. Bi Chunlei, Duhai Ou.

Introduction

Self-test (IVD) equipment manufacturers to provide the user can safely use and achieve its expected performance of devices used in vitro diagnostic information. Charge Minute instructions for the use of safe and proper operation IVD instrument is required. The form and level of detail as the intended use and the country-specific Regulatory changes. Global Harmonization Task Force (GHTF) encourages global regulatory system for medical devices to converge. Eliminate differences between jurisdictions and regulations can be So patients earlier access to new technologies and treatments, see reference [7]. This standard provides coordination IVD instruments for self labeling requirements basis. This section is concerned only with IVD instruments and equipment to the expected use of the self-test information provided. This section is intended and GB/T 29791.1 United In combination, the standard contains the definition of common requirements for the information provided by the manufacturer and marked general concepts. This section based on EN592 [5]. In order to comply with ISO /IEC Guide Part 2 [4], the text has been modified, but the requirements, including the GB/T 29791.1 of the requirements, substantially equivalent to the initial harmonized European standards. This section is intended to support all GHTF participating countries, as well as Other embodiments or planning to implement basic labeling requirements IVD medical device labeling regulations of the State. For IVD instruments and reagents is expected as the system provided by the same manufacturer for use with this section and is also expected to GB/T 29791.1 and GB/T 29791.4 used together. In vitro diagnostic medical devices Information supplied by the manufacturer (labeling) Part 5. In vitro diagnostic instruments for self

1 Scope

This section GB/T 29791 provides for self-test use in vitro diagnostics (IVD) equipment manufacturers to provide the information requested. This section also applies to equipment and devices for self expectations and in vitro diagnostic medical instruments used in conjunction. This section also applies to IVD Annex. This section does not apply to. a) equipment maintenance or repair instructions; b) in vitro diagnostic reagents, including calibrators and control of controlled substances for the agent; c) in vitro diagnostic instruments for professional use.

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. ISO 14971 Medical Device Risk Management for Medical Device Applications (Medicaldevices-Applicationofriskman- agementtomedicaldevices) Symbols - Part 1 ISO 15223-1 for medical equipment with medical device labels, labeling and information. General requirements (Medicaldevices-Symbolstobeusedwithmedicaldevicelabels, labelingandinformationtobesup- plied-Part 1. Generalrequirements) ISO 18113-1 In vitro diagnostic medical device manufacturers to provide information (labeling) - Part 1. Terms, definitions and general requirements (Invitrodiagnosticmedicaldevices-Informationsuppliedbythemanufacturer (labeling) -Part 1. Terms, definitionsandgeneralrequirements) IEC 61010-1 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements (Safetyrequire- mentsforelectricalequipmentformeasurement, controlandlaboratoryuse-Part 1. Generalrequire- ments) IEC 61010-2-101 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101. In vitro diagnostic (IVD) Medical With special equipment requirements (Safetyrequirementsforelectricalequipmentformeasurement, controlandlabora- toryuse-Part 2-101. Particularrequirementsforinvitrodiagnostic (IVD) medicalequipment) IEC 61326-2-6 measurement, control and laboratory use EMC requirements for electrical equipment Part 2-6. Particular requirements for in vitro Diagnostic (IVD) medical equipment (Electricalequipmentformeasurement, controlandlaboratoryuse-EMCre- quirements-Part 2-6. Particularrequirements-Invitrodiagnostic (IVD) medicalequipment) IEC 62366 Medical Devices to use engineering applications (Medicaldevices-Applicationof on medical devices usabilityengineeringtomedicaldevices) EN980 medical devices used in the labeling symbol (Symbolsforuseinthelabelingofmedicaldevices) ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 29791.5-2013_English be delivered?

Answer: Upon your order, we will start to translate GB/T 29791.5-2013_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 29791.5-2013_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 29791.5-2013_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.