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GB/T 25440.1-2021 English PDF

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Q: Should I purchase the latest version GB/T 25440.1-2021?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 25440.1-2021 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.

US$404.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 25440.1-2021: Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
Status: Valid

GB/T 25440.1: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 25440.1-2021	404	Add to Cart	3 days	Retrieval and analysis of surgical implants - Part 1: Retrieval and handling	Valid
GB/T 25440.1-2010	914	Add to Cart	4 days	Retrieval and analysis of surgical implants -- Part 1: Retrieval and handling	Obsolete

Similar standards

GB/T 39381.1 YY/T 1680 YY/T 1571 GB/T 20405.5 GB/T 20405.4 GB/T 25440.2

Basic data

Standard ID: GB/T 25440.1-2021 (GB/T25440.1-2021)
Description (Translated English): Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C45
Word Count Estimation: 23,219
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 25440.1-2021: Retrieval and analysis of surgical implants - Part 1: Retrieval and handling

---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.
Retrieval and analysis of surgical implants - Part 1.Retrieval and handling ICS 11.040.40 C45 National Standards of People's Republic of China Replace GB/T 25440.1-2010 Removal and analysis of surgical implants Part 1.Take-out and disposal (ISO 12891-1.2015, IDT) Released on 2021-11-26 2022-12-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee

Foreword Ⅰ 1 Scope 1 2 Terms and definitions 1 3 Method 1 4 Take out adjacent tissues and body fluids for analysis 7 5 Infection Control 7 Appendix A (informative appendix) It is recommended to record the minimum information related to the removal of surgical implants 11 Appendix B (informative appendix) General procedures for removing surgical implants for sterilization 13 Appendix C (informative appendix) Take out tissue samples and analysis of body fluids 17 Reference 18

Foreword

GB/T 25440 "Removal and Analysis of Surgical Implants" is divided into two parts. ---Part 1.Take out and handle; ---Part 2.Analysis of the removal of surgical implants. This part is Part 1 of GB/T 25440. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces GB/T 25440.1-2010 "Removal and Analysis of Surgical Implants Part 1.Removal and Processing", and Compared with GB/T 25440.1-2010, in addition to editorial changes, the main technical changes are as follows. ---Modified the scope of application of the standard (see Chapter 1, Chapter 1 of the.2010 edition); --- Deleted "inclusions" (see 2.2 in the.2010 edition), "biological products" (see 2.3 in the.2010 edition), and "clinical samples" (see.2010 The terms of 2.4), “medical waste” (see 2.6 in.2010), “refrigeration materials” (see 2.7 in.2010), and definition; --- Modified clinical medical records (see 3.1, 3.2 in.2010 edition), collection of surgical implants (see 3.3, 3.7.2 in.2010 edition), group Tissue and body fluid sample collection (see 3.4,.2010 version 3.6), removal of surgical implants, tissue, body fluid labels (3.6,.2010 Version 3.7.3), cleaning of removing surgical implants (see 3.7,.2010 version 4.2.3) and disinfection (3.8,.2010 version 4.2.4), the packaging of the implant, tissue, and body fluid to be transported (see 3.9, 4.3 in the.2010 edition), and the surgical implant is attached The content of the document (3.12,.2010 version 4.3.2.5), the image record of the removal activity (see 3.5), and the cleaning after transportation have been added. And documentation during disinfection (see 3.14), inspection, analysis and storage (see 3.15); ---Modified the content of "Removing adjacent tissues and analysis of body fluids" (see Chapter 4, Chapter 5 of the.2010 Edition); ---Added "If you need to incinerate human waste, you should put the waste in a leak-proof, flammable container, and mark the'harmful biological waste Junk'" (see 5.5.1). The translation method used in this part is equivalent to ISO 12891-1.2015 ``Removal and Analysis of Surgical Implants Part 1.Removal and Disposal reason". This section has made the following editorial changes. --- Added "This part is applicable to the removal of surgical implants and related tissues and body fluids" in the scope, which improves the application of this document Use boundaries; --- Replace ISO 12891-2 with GB/T 25440.2, which is equivalent to the international standard (see note in Chapter 4). Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is under the jurisdiction of the National Standardization Technical Committee for Surgical Implants and Orthopaedic Devices (SAC/TC110). Drafting organizations of this section. Tianjin Medical Device Quality Supervision and Inspection Center, Trauson Medical Devices (China) Co., Ltd., Beijing Natongke Technology Group Co., Ltd. The main drafters of this section. Li Libin, Li Jia, Li Yuan, Chen Changsheng, Yang Qun, Dong Xiang, Li Mei. The previous releases of the standards replaced by this part are as follows. ---GB/T 25440.1-2010. Removal and analysis of surgical implants Part 1.Take-out and disposal

1 Scope

This part of GB/T 25440 specifies the method of removal and disposal of surgical implants and related tissues and body fluids. In particular, the headquarters It specifies the necessary steps for the safe and correct acquisition of clinical medical records, inspection before removal, collection, marking, cleaning, disinfection, recording, packaging and transportation. This section also provides guidance and recommendations for infection control. This section applies to the removal of surgical implants and related tissues and body fluids. This section does not apply to unintentional collection and retrieval activities, but such activities can use the practical information provided in the relevant provisions of this section.

2 Terms and definitions

The following terms and definitions apply to this document. 2.1 Absorbent Material that can absorb liquids. Note. It can be particulate or non-particulate materials. 2.2 Contamination Unexpected addition of substances or changes to the sample, including exposure to potential sources of infection. 2.3 Infectious waste Waste that contains or may contain pathogenic microorganisms that cause disease in the human body. 2.4 Outer shipping container The outermost container used for the final shipping package. 2.5 Primary container Tubes, sealed bags, or other impervious containers used to contain transport materials. 2.6 Secondary container(s) The container used to hold the primary container.

3 method

3.1 Obtaining the implant and the patient's clinical medical records The clinical history of patients and surgical implants should be obtained and recorded as much as possible. The medical record should contain at least the following. ......

Image

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 25440.1-2021_English be delivered?

Answer: Upon your order, we will start to translate GB/T 25440.1-2021_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 25440.1-2021_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 25440.1-2021_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.

Question 5: Should I purchase the latest version GB/T 25440.1-2021?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 25440.1-2021 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.