HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY/T 1473-2023 English PDF

US$509.00 ยท In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1473-2023: Aqueous Urea Solution Dispensers
Status: Valid

YY/T 1473: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1473-2023English509 Add to Cart 4 days [Need to translate] Aqueous Urea Solution Dispensers Valid YY/T 1473-2023
YY/T 1473-2016English839 Add to Cart 4 days [Need to translate] Guide to the development and inclusion of safety aspects in Standards for medical devices Obsolete YY/T 1473-2016

PDF similar to YY/T 1473-2023


Standard similar to YY/T 1473-2023

YY/T 1465.6   YY/T 1465.4   YY/T 1474   YY/T 1465.7   

Basic data

Standard ID YY/T 1473-2023 (YY/T1473-2023)
Description (Translated English) Aqueous Urea Solution Dispensers
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.01; 01.120
Word Count Estimation 24,287
Date of Issue 2023-01-13
Date of Implementation 2024-01-15
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements and recommendations for including safety-related content in medical device standards. These requirements and recommendations are based on established risk management concepts and approaches. This standard applies to the safety-related content of personnel, property, environment or a combination of these factors involved in medical device standards. In this standard, the term "product" includes a single medical device or a system consisting of one or more medical devices (which may also be used in combination with non-medical devices).

YY/T 1473-2023: Aqueous Urea Solution Dispensers

---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.
Replacing YY/T 1473-2016 Released 2023-01-13 2024-01-15 Implementation ICS 11.040.01; 01.120CCS C 30 Guidelines for Standardization of Medical Devices Development of standards involving security content Guide for standardization for medical devices- Inclusion of safety aspects in the development of standards (ISO /IEC GUIDE 63.2019, Guide to the development and inclusion of aspects of safety in International Standards for medical devices, MOD)

table of contents

Preface I Introduction III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Use of the terms "safe", "safe", "effective" and "effectiveness"3 4.1 Security 3 4.2 Safe 3 4.3 Effective 4 4.4 Effectiveness 4 5 Principles for Safety Content in Medical Device Standards 4 5.1 Scope of medical device standards involving safety content4 5.2 Purpose of medical device standards involving safety content 4 5.3 Standard type 5 5.4 Looking at security issues from a practical perspective 5 5.5 Harmonization of medical device standards 6 5.6 Meaning of standards used by laws or regulations6 6 The nature of the risk6 6.1 Elements of Risk 6 6.2 Systematic or random risks6 7 Risk-based process for developing medical device standards involving safety content 8 7.1 General 8 7.2 Preparation 8 7.3 Drafting 10 7.4 Validation of standards 17 7.5 Conclusion 17 8 Overview of the application of medical device standards with safety aspects within a risk management framework17 APPENDIX A (INFORMATIVE) PRODUCT SAFETY STANDARDS AND PROCESS SAFETY STANDARDS19 APPENDIX B (INFORMATIVE) RISK INFORMATION20 Reference 21

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents" drafting. This document replaces YY/T 1473-2016 "Guidelines for Standardization of Medical Devices Standardization Involving Safety Requirements". and Compared with YY/T 1473-2016, except for structural adjustment and editorial changes, the main technical changes are as follows. --Changed some terms, most of which originated from GB/T.20002.4-2015, and changed based on GHTF/SG1/N055.2009 definition of "manufacturer" (see Chapter 3, Chapter 2 of the.2016 edition); --Add guidance on the use of terms such as "safety", "safe", "effective" and "effectiveness" (see Chapter 4); --Added the general principles in the process of developing medical device standards involving safety content based on risk (see 7.1); --Increased the preparatory work in the process of risk-based development of medical device standards involving safety content, including the identification of safety content The need for new or revised standards for content and the establishment of a risk management framework against which standards are developed (see 7.2.1, 7.2.2); --Increased the general rules drafted in the process of risk-based development of medical device standards involving safety content and the iterative process of risk management process (see 7.3.1, 7.3.2); --Changed "Hazards and dangerous situations related to medical devices" (see 7.3.4.3, 4.5.2 of the.2016 edition), and deleted "hazards related to patients Hazards (sources) and hazardous situations related to the use of situation" (see 4.5.4 of the.2016 edition), and "exposure to hazards (sources) and hazardous situations due to occupational reasons" was deleted (see.2016 edition version 4.5.5); -- Changed "Risk Estimation" (see 7.3.5, 4.7 of the.2016 edition); -- Changed "risks controlled by standards" to "identified risk controls" (see 7.3.7, 4.10.1 and 4.10.2 of the.2016 edition); added "Product standard requirements or process standard requirements as an appropriate risk control" (see 7.3.7.3), added "in the product standard or process Marked as a risk control measure in the standard" (see 7.3.7.4), added "packaging" (see 7.3.7.5); -- Added "Consider all identified hazards/hazardous situations" (see 7.3.11); --Deleted "promoting the implementation of ISO 14971 through product standards or process standards" (see Chapter 5 of the.2016 edition); -- Changed Figure 1 to better illustrate how the sequence of events converts a hazard into a hazardous situation that could result in injury (see Figure 1,.2016 Figure 1 of the annual edition); -- Added Figure 2 to illustrate the iterative process of risk management (see Figure 2). This document is modified to adopt ISO /IEC Guide 63.2019 "Guidelines for the Development of International Standards for Medical Devices Involving Safety Content". this document The technical differences from ISO /IEC Guide 63.2019 and their reasons are as follows. --The term "medical device" has been deleted. Since the Chinese standards and medical device regulations have definitions for "medical device", this document is no longer repeat. The following editorial changes have been made to this document. --In order to coordinate with the existing standard, the name of the standard is changed to "Guidelines for Medical Device Standardization Work Standardization Involving Safety Content". Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC 221). This document was drafted by. China National Institutes for Food and Drug Control, Beijing Guoyi Huaguang Certification Co., Ltd., Shanghai Medical Device Inspection and Research Institute Research Institute, Shandong Medical Device and Drug Packaging Inspection Research Institute, Tianjin Medical Device Quality Supervision and Inspection Center, Shenzhen Mindray Biomedical Electronics Subsidiary Co., Ltd., Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd. The main drafters of this document. Zheng Jia, Shao Yubo, Wang Meiying, He Jun, Hou Li, Li Libin, Wang Hongman, Li Yong, Li Zhaohui, Wang Huifang, Ye Shasha, Zhang Jianfeng, Ai Yingying. The release status of previous versions of this document and the documents it replaces are as follows. --First published as YY/T 1473-2016 in.2016; -- This is the first revision.

Introduction

This document provides information on how standards writers can incorporate safety standards when developing medical device standards, including management system standards related to medical Aspects of content provide practical guidance. This document is based on the principles of risk management and GB/T.20002.4-2015, addressing the need. The security concepts described in this document are relevant to the protection of patients (i.e. recipients of healthcare), those providing healthcare and others who may be affected members are closely related. Safety is also concerned with harm to property or the environment. The methods described in this document aim to reduce the life cycle of medical devices (including design, production, distribution, installation, use, service, maintenance and destruction or Disposal), taking into account the entire life cycle of the medical device (including intended use and reasonably foreseeable misuse), the goal is to provide Achieve acceptable risks to people, property and the environment. Since different situations require different approaches to security, it is not possible to provide precise requirements and recommendations for every situation. Setting standards for medical device manufacturers versus setting standards for health care providers and medical institutions is an example of a different situation. However, if Following this document on a judged "use where applicable" basis will help develop standards that address safety content that is consistent with generally accepted consistent with the state-of-the-art technology. Guidelines for Standardization of Medical Devices Development of standards involving security content

1 Scope

This document provides standards writers with requirements and recommendations for including safety-related content in medical device standards. These requirements and The recommendations are based on established risk management concepts and approaches. This document applies to the safety-related content of personnel, property, environment or a combination of these factors involved in medical device standards. In this document, the term "product" includes a single medical device or a combination of one or more medical devices (may also be used in combination with non-medical devices) composed system.

2 Normative references

This document has no normative references.

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 hurt harm Injury or damage to human health, or damage to property or the environment. [Source. GB/T.20002.4-2015, 3.1, with modifications] 3.2 danger hazard potential source of harm (3.1). [Source. GB/T.20002.4-2015, 3.2] 3.3 hazardous situation Situation in which people, property or the environment are exposed to one or more hazards (3.2). [Source. GB/T.20002.4-2015, 3.4] 3.4 intended use intended use intended use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer (3.6) NOTE. The intended medical indication, patient population, body part or tissue type with which the medical device interacts, user characteristics, environment of use, and principle of operation are Typical elements of use. 3.5 life cycle life cycle All stages in the life of a medical device, from initial concept to eventual decommissioning and disposal.

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1473-2023_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1473-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1473-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1473-2023_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 [email protected]. 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.

Question 5: Should I purchase the latest version YY/T 1473-2023?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1473-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.