YY/T 0809.1-2010 English PDF

US$394.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0809.1-2010: Implants for surgery. Partial and total hip joint prostheses. Part 1: Classification and designation of dimensions
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0809.1-2010	394	Add to Cart	3 days	Implants for surgery. Partial and total hip joint prostheses. Part 1: Classification and designation of dimensions	Valid

Similar standards

YY/T 0809.10   YY/T 0809.2   YY/T 0809.12   YY/T 0810.1   YY/T 0809.13   YY/T 0809.4   

Basic data

Standard ID: YY/T 0809.1-2010 (YY/T0809.1-2010)
Description (Translated English): Implants for surgery. Partial and total hip joint prostheses. Part 1: Classification and designation of dimensions
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 20,228
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: ISO 21534; ISO 21535
Adopted Standard: ISO 7206-1-2008, IDT
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the part and the whole bit prosthesis classification methods and standardized dimensions.

YY/T 0809.1-2010: Implants for surgery. Partial and total hip joint prostheses. Part 1: Classification and designation of dimensions

---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.
Implants for surgery.Partial and total hip joint prostheses.Part 1. Classification and designation of dimensions ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical implants, and total hip prostheses Part 1. Classification and Dimensioning Part 1. Classificationanddesignationofdimensions (ISO 7206-1..2008, IDT) 2010-12-27 release 2012-06-01 implementation State Food and Drug Administration issued Directory Preface I Introduction II 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 Category 4 5 Dimensions 7

Foreword

YY/T 0809 "Surgical Implants Part and Total Hip Joint" is expected to be divided into the following sections. - Part 1. Classification and dimensioning; - Part 2. metal, ceramic and plastic joints; - Part 4. Determination of fatigue properties of the femoral component; Part 6. Determination of fatigue properties of the head and neck of the femoral component; - Part 8. Fatigue properties of the femoral component with torque; Part 10. Determination of anti - static loading of combined femoral head. This part is part 1 of YY/T 0809. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part uses the translation method equivalent to ISO 7206-1..2008 "Surgical Implant Section and Total Hip Joints Part 1. Section Class and dimension ". Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is composed of the National Committee for the Standardization of Surgical Implants and Orthopedic Instruments, the Subcommittee on Materials and Orthopedic Implants (SAC / TC110/SC1). This part of the drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Bermuda material high-tech Co., Ltd. The main drafters of this part. Li Libin, Li Nan, Dong Shuangpeng, Jiao Yongzhe, Song Duo, Liang Fanghui, Li Tong.

Introduction

Partial and total hip prostheses are designed to transfer loads and allow movement under high stress conditions. Currently used worldwide for hip clearance There are many different designs for the prosthesis, and this part of the YY/T 0809 will be passed through a detailed classification system for the most common hip prosthesis To elaborate. The size of the selected type of hip prosthesis will be the basis for all test criteria in YY/T 0809. Surgical implants, and total hip prostheses Part 1. Classification and Dimensioning

1 Scope

This part of YY/T 0809 specifies the classification and standardized dimensioning of partial and total hip prostheses.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. ISO 21534 Passive Surgical Implants Joint Replacement Special Requirements (Non-activesurgicalimplants-Joint replacementimplants-Particularrequirements ISO 21535 Passive Surgical Implants Joint Replacement Implants Hip Replacement Implants Specific requirements (Non-active surgicalimplants-Jointreplacementimplants-Specificrequirementsforhip-jointreplacementim- plants

3 terms and definitions

ISO 21534 and ISO 21535 and the following terms and definitions apply to this document. 3.1 Bipolar femoral component bipolarfemoralcomponent A hip replacement member connected to the femoral head and a convex surface connected to the physiological acetabulum. 3.2 Bone cement A radiopaque or radiopaque acrylic resin adhesive for immobilizing the implanted part, a sterile powder and a sterile liquid, The number of determinations is provided as a unit, and its form is suitable for implantation when mixed. 3.3 Bone cement hip replacement parts cementedhipjointreplacement The hip replacement component is expected to be secured to the bone by bone cement. 3.4 Non - cement - type hip replacement parts cementlesshipjointreplacement The hip replacement component is intended to be secured to the bone by means of press fit and/or bone ingrowth surface structures. 3.5 Modular femoral stem modular A femoral stem consisting of two or more components (without a combined femoral head, femoral neck) is expected to be assembled preoperatively or intraoperative. 3.6 Monolithic monoblocstem Consists of a femoral stem that consists of a single part of the femoral head, with no components. ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0809.1-2010_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0809.1-2010_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 YY/T 0809.1-2010_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0809.1-2010_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.