硅凝胶填充乳房植入物 可浸提物质检测

YY/T 1555.2-2018 硅凝胶填充乳房植入物专用要求 硅凝胶填充物性能要求 第2部分：可浸提物质限量要求

YY/T 1457-2016 源外科植入物 硅凝胶填充乳房植入物中寡聚硅氧烷类物质测定方法

YY/T 1555.1-2017 硅凝胶填充乳房植入物专用要求硅凝胶填充物性能要求第1部分：易挥发性物质限量要求

ASTM F2051-00(2014 可植入的盐水填充乳房假体的标准规格

1.1x00a0;This specification covers the requirements for single

Standard Specification for Implantable Saline Filled Breast Prosthesis

ASTM F2051-00 可植入的盐水填充的乳房假体标准规范

1.1 This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses

Standard Specification for Implantable Saline Filled Breast Prosthesis

ASTM F2051-00(2006 可植入的盐水填充的乳房假体标准规范

1.1 This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses

Standard Specification for Implantable Saline Filled Breast Prosthesis

YY 0647-2008 源外科植入物.乳房植入物的专用要求

本标准规定了供临床使用乳房植入物（或称为乳房假体，乳房植入体和人工乳房等，以下简称植入物）的专用要求。 本标准对预期性能、设计属性、材料、设计评价、制造、灭菌、包装和由制造商提供的信息等做了具体说明。同时考虑到植入物的安全性因素

Non-active surgical implants.Mammary implants—Particular requirements

ISO 14607:2002 外科植入物.乳房植入物的特殊要求

This International Standard provides specific requirements for mammary implants for clinical practice. With regard to safety, it specifies intended

Implants for surgery - Specific requirements for mammary implants

ASTM F703-96(2002)e1 可植入假乳房

1.1 This specification covers the requirements for silicone gel-filled, saline inflatable silicone gel-filled, and saline inflatable, smooth-shell

Standard Specification for Implantable Breast Prostheses

ASTM F703-96(2002 可植入假乳房

1.1 This specification covers the requirements for silicone gel-filled, saline inflatable silicone gel-filled, and saline inflatable, smooth-shell

Standard Specification for Implantable Breast Prostheses

ASTM F703-96 可植入假乳房

1.1 This specification covers the requirements for silicone gel filled, saline inflatable silicone gel filled, and saline inflatable, smooth shell

Standard Specification for Implantable Breast Prostheses

KS P ISO 14607:2009 非有源外科植入物.乳房植入物.特殊要求

이 표준은 임상 시험용 유방 이식재에 대한 특정 요건을 제시한다.안전성에 있어서

Implants for surgery-Specific requirements for mammary implants

YY/T 0647-2021 源外科植入物 乳房植入物的专用要求

EN ISO 14607:2018 非活性外科植入物.乳房植入物.特殊要求

Non-active surgical implants - Mammary implants - Particular requirements

ISO 14607:2007 非有源外科植入物.乳房植入物.特殊要求

This International Standard specifies particular requirements for mammary implants for clinical practice. With regard to safety, this International

Non-active surgical implants - Mammary implants - Particular requirements

YY/T 1555.2-2018 硅凝胶填充乳房植入物专用要求 硅凝胶填充物性能要求 第2部分：可浸提物质限量要求

YY/T 1457-2016 源外科植入物 硅凝胶填充乳房植入物中寡聚硅氧烷类物质测定方法

YY/T 1555.1-2017 硅凝胶填充乳房植入物专用要求硅凝胶填充物性能要求第1部分：易挥发性物质限量要求

ASTM F2051-00(2014 可植入的盐水填充乳房假体的标准规格

1.1x00a0;This specification covers the requirements for single

Standard Specification for Implantable Saline Filled Breast Prosthesis

ASTM F2051-00 可植入的盐水填充的乳房假体标准规范

1.1 This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses

Standard Specification for Implantable Saline Filled Breast Prosthesis

ASTM F2051-00(2006 可植入的盐水填充的乳房假体标准规范

1.1 This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses

Standard Specification for Implantable Saline Filled Breast Prosthesis

YY 0647-2008 源外科植入物.乳房植入物的专用要求

本标准规定了供临床使用乳房植入物（或称为乳房假体，乳房植入体和人工乳房等，以下简称植入物）的专用要求。 本标准对预期性能、设计属性、材料、设计评价、制造、灭菌、包装和由制造商提供的信息等做了具体说明。同时考虑到植入物的安全性因素

Non-active surgical implants.Mammary implants—Particular requirements

ISO 14607:2002 外科植入物.乳房植入物的特殊要求

This International Standard provides specific requirements for mammary implants for clinical practice. With regard to safety, it specifies intended

Implants for surgery - Specific requirements for mammary implants

ASTM F703-96(2002)e1 可植入假乳房

1.1 This specification covers the requirements for silicone gel-filled, saline inflatable silicone gel-filled, and saline inflatable, smooth-shell

Standard Specification for Implantable Breast Prostheses

ASTM F703-96(2002 可植入假乳房

1.1 This specification covers the requirements for silicone gel-filled, saline inflatable silicone gel-filled, and saline inflatable, smooth-shell

Standard Specification for Implantable Breast Prostheses

ASTM F703-96 可植入假乳房

1.1 This specification covers the requirements for silicone gel filled, saline inflatable silicone gel filled, and saline inflatable, smooth shell

Standard Specification for Implantable Breast Prostheses

KS P ISO 14607:2009 非有源外科植入物.乳房植入物.特殊要求

이 표준은 임상 시험용 유방 이식재에 대한 특정 요건을 제시한다.안전성에 있어서

Implants for surgery-Specific requirements for mammary implants

YY/T 0647-2021 源外科植入物 乳房植入物的专用要求

EN ISO 14607:2018 非活性外科植入物.乳房植入物.特殊要求

Non-active surgical implants - Mammary implants - Particular requirements

ISO 14607:2007 非有源外科植入物.乳房植入物.特殊要求

This International Standard specifies particular requirements for mammary implants for clinical practice. With regard to safety, this International

Non-active surgical implants - Mammary implants - Particular requirements