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This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is ...
https://sales.sfs.fi/julkaisu.html.stx?id=911768
This part of EN 61249 gives requirements for properties of prepreg that is mainly intended to be used as bonding sheets in connection with laminates according to EN 61249-2-8 when manufacturing multilayer boards according to EN 62326-4. This material may be also used to bond other types of lamina ...
https://sales.sfs.fi/julkaisu.html.stx?id=352369
This part of EN 61249 gives requirements for properties of prepreg that is mainly intended to be used as bonding sheets in connection with laminates according to EN 61249-2-8 when manufacturing multilayer boards according to EN 62326-4. This material may be also used to bond other types of lamina ...
https://sales.sfs.fi/julkaisu.html.stx?id=352345
IEC 61249-4-19:2013 gives requirements for properties of prepreg that is mainly intended to be used as bonding sheets in connection with laminates according to IEC 61249-2-40 when manufacturing multilayer boards according to IEC 62326-4. Multilayer boards comprised of these materials are suitable ...
https://sales.sfs.fi/julkaisu.html.stx?id=352343
IEC 61249-4-18:2013 gives requirements for properties of prepreg that is mainly intended to be used as bonding sheets in connection with laminates according to IEC 61249-2-39 when manufacturing multilayer boards according to IEC 62326-4. Multilayer boards comprised of these materials are suitable ...
https://sales.sfs.fi/julkaisu.html.stx?id=352337
IEC 61249-4-17:2009(E) gives requirements for properties of prepreg that are mainly intended to be used as bonding sheets in connection with laminates according IEC 61249-2-38 when manufacturing multilayer boards according to IEC 62326-4. Multilayer boards comprised of these materials are suitabl ...
https://sales.sfs.fi/julkaisu.html.stx?id=352333
IEC 61249-4-16:2009(E) gives requirements for properties of prepreg that are mainly intended to be used as bonding sheets in connection with laminates according IEC 61249-2-37 when manufacturing multilayer boards according to IEC 62326-4. Multilayer boards comprised of these materials are suitabl ...
https://sales.sfs.fi/julkaisu.html.stx?id=352331
IEC 61249-4-15:2009(E) gives requirements for properties of prepreg that are mainly intended to be used as bonding sheets in connection with laminates according IEC 61249-2-35 when manufacturing multilayer boards according to IEC 62326-4. Multilayer boards comprised of these materials are suitabl ...
https://sales.sfs.fi/julkaisu.html.stx?id=352327
IEC 61249-4-14:2009(E) gives requirements for properties of prepreg that are mainly intended to be used as bonding sheets in connection with laminates according to IEC 61249-2-36 when manufacturing multilayer boards according to IEC 62326-4. Multilayer boards comprised of these materials are suit ...
https://sales.sfs.fi/julkaisu.html.stx?id=352323
This part of EN 61249 gives requirements for properties of prepreg that is mainly intended to be used as bonding sheets in connection with laminates according EN 61249-2-7 when manufacturing multilayer boards in conformity with EN 62326-4. This material may be also used to bond other types of lam ...
https://sales.sfs.fi/julkaisu.html.stx?id=352321
CEN ISO/TR 24971:2020:en – Medical devices. Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
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SFS-EN 61249-4-5:en – Materials for printed boards and other interconnecting structures – Part 4-5: Sectional specification set for prepreg materials, unclad – Polyimide, modified or unmodified, woven E-glass prepreg of defined flammability
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SFS-EN 61249-4-2:en – Materials for printed boards and other interconnecting structures – Part 4-2: Sectional specification set for prepreg materials, unclad – Multifunctional epoxide woven E-glass prepreg of defined flammability
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SFS-EN 61249-4-19:en – Materials for printed boards and other interconnecting structures – Part 4-19: Sectional specification set for prepreg materials, unclad (for the manufacture of multilayer boards) – High performance non-halogenated epoxide woven E-glass prepreg of defined flammability (vertical burning test) for lead-free assembly
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SFS-EN 61249-4-18:en – Materials for printed boards and other interconnecting structures – Part 4-18: Sectional specification set for prepreg materials, unclad (for the manufacture of multilayer boards) – High performance epoxide woven E-glass prepreg of defined flammability (vertical burning test) for lead-free assembly
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SFS-EN 61249-4-17:en – Materials for printed boards and other interconnecting structures – Part 4-17: Sectional specification set for prepreg materials, unclad (for the manufacture of multilayer boards) – Non-halogenated epoxide woven E-glass prepreg of defined flammability (vertical burning test) for lead-free assembly
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SFS-EN 61249-4-16:en – Materials for printed boards and other interconnecting structures – Part 4-16: Sectional specification set for prepreg materials, unclad (for the manufacture of multilayer boards) – Multifunctional non-halogenated epoxide woven E-glass prepreg of defined flammability (vertical burning test) for lead-free assembly
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SFS-EN 61249-4-15:en – Materials for printed boards and other interconnecting structures – Part 4-15: Sectional specification set for prepreg materials, unclad (for the manufacture of multilayer boards) – Multifunctional epoxide woven E-glass prepreg of defined flammability (vertical burning test) for lead-free assembly
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SFS-EN 61249-4-14:en – Materials for printed boards and other interconnecting structures – Part 4-14: Sectional specification set for prepreg materials, unclad (for the manufacture of multilayer boards) – Epoxide woven E-glass prepreg of defined flammability (vertical burning test) for lead-free assembly
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SFS-EN 61249-4-12:en – Materials for printed boards and other interconnecting structures – Part 4-12: Sectional specification set for prepreg materials, unclad – Non-halogenated multifunctional epoxide woven E-glass prepreg of defined flammability
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