|
US$169.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0816-2010: Implants for surgery. Malleable wires for use as sutures and other surgical applications
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0816-2010 | English | 169 |
Add to Cart
|
3 days [Need to translate]
|
Implants for surgery. Malleable wires for use as sutures and other surgical applications
| Valid |
YY/T 0816-2010
|
PDF similar to YY/T 0816-2010
Basic data | Standard ID | YY/T 0816-2010 (YY/T0816-2010) | | Description (Translated English) | Implants for surgery. Malleable wires for use as sutures and other surgical applications | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 7,787 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB/T 228; GB/T 238; GB/T 239; YY/T 0605.5; YY/T 0640; ISO 5832-1; ISO 5832-2; ISO 5832-9; ASTM F86 | | Adopted Standard | ISO 10334-1994, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard provides for sewing or other forms of surgery and implant tissue fixed with a flexible wire character size and mechanical properties and test methods. Mechanical properties, including tensile strength, elongation, bending and torsional damage abilities. This standard does not involve surface finish. | YY/T 0816-2010: Implants for surgery. Malleable wires for use as sutures and other surgical applications
---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.Malleable wires for use as sutures and other surgical applications
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Surgical implants and other surgical sutures
Flexible wire
(ISO 10334.1994, MOD)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard uses redrafted Law Amendment uses ISO 10334.1994 "surgical sutures and other surgical implants with a flexible wire."
This standard and ISO 10334.1994 in comparison, only normative references have been adjusted to technical differences, in order to adapt to China
Technical conditions, adjust the focus reflected in Chapter 2, "Normative references", the specific adjustments are as follows.
--- Instead of using the ISO 5832-1 ISO 5832-1. 1987;
--- Instead of using the ISO 5832-2 ISO 5832-2.1993;
--- With YY/T 0605.5 replaces ISO 5832-5.1993;
--- Instead of using the ISO 5832-9 ISO 5832-9.1992;
--- With YY/T 0640 instead of ISO 6018. 1987;
--- With GB/T 228 instead of ISO 6892. 1984;
--- With GB/T 239 instead of ISO 7800. 1984;
--- With GB/T 238 instead of ISO 7801. 1984;
--- With ASTMF86 instead ASTMF86-91.
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 standard by the national surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee
(SAC/TC110/SC1) centralized.
This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Li Yuan, Furui Zhi, Zhang Lu.
Surgical implants and other surgical sutures
Flexible wire
1 Scope
This standard specifies the surgical sutures or for other forms of organization and implant fixation with flexible wire sizes and machinery
Performance and test methods. Mechanical properties, including tensile strength, elongation, bending and torsion capability damaged.
This standard does not involve surface finish.
Note 1. In the case of wire twisting and knotting should not be broken, the surface should not appear fracturing, cracks or cracks.
Note 2. The wire may be used simultaneously with other implants. In this case, the composition of the D and E of stainless steel wire (see ISO 5832-1) only
And the corresponding stainless steel implants used in common; similarly, the use of high nitrogen stainless steel wire and other high nitrogen stainless steel can only co-implant
With use. This is done to reduce that may arise between the wire and the other implant galvanic corrosion.
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/T 228 metal materials at room temperature tensile test method (GB/T 228-2002, eqvISO 6892.1998)
GB/T 238 metal material wire repeated bending test method (GB/T 238-2002, ISO 7801. 1984, IDT)
GB/T 239 metal wire torsion test method (GB/T 239-1999, eqvISO 7800. 1984)
YY/T 0605.5 surgical implants of metallic materials - Part 5. Wrought cobalt - chromium - tungsten - nickel alloy (YY/T 0605.5-2007,
ISO 5832-5.2005, IDT)
YY/T 0640 General requirements for passive surgical implants (YY/T 0640-2008, ISO 14630.2005, IDT)
ISO 5832-1 Implants for surgery - Metallic materials - Part 1. Forged Stainless Steel (Implantsforsurgery-Metalic
materials-Part 1. Wroughtstainlesssteel)
ISO 5832-2 Implants for surgery - Metallic materials - Part 2. Titanium (Implantsforsurgery-Metalic
materials-Part 2. Unaloyedtitanium)
ISO 5832-9 Implants for surgery - Metallic materials - Part 9. Forged high nitrogen stainless steel (Implantsforsurgery-
Metalicmaterials-Part 9. Wroughthighnitrogenstainlesssteel)
ASTMF86 metal surgical implant surface treatment and marking (StandardPracticeforSurfacePreparationand
MarkingofMetalicSurgicalImplants)
3 Materials
Flexible wire material can be in line with the requirements of ISO 5832-1 forged stainless steel, titanium comply with the requirements of ISO 5832-2, consistent with
Forging high nitrogen requirements of ISO 5832-9 stainless steel, in line with forged cobalt-chromium tungsten nickel YY/T 0605.5 requirements.
4 Surface Treatment
When the customer needs, it can be wire passivation, passivation procedures based ASTMF86.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0816-2010_English be delivered?Answer: Upon your order, we will start to translate YY/T 0816-2010_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 0816-2010_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0816-2010_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+ countriesQuestion 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.
|