ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary standard[1] for the application of risk management to medical devices.[2] "Voluntary standards do not replace national laws, with which standards' users are understood to comply and which take precedence" over voluntary standards[3] such as ISO 13485 and ISO 14971. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51,[4] and ISO/IEC Guide 63.[5] The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971.[6]
Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production.[7][8]
ISO 14971:2012 was harmonized with respect to the three European Directives associated with medical devices through the three 'Zed' Annexes (ZA, ZB & ZC). The Annex ZA harmonized ISO 14971:2012 with the Medical Devices Directive 93/42/EEC of 1993.[9] The Annex ZB harmonized ISO 14971:2012 with the Active Implantable Medical Device Directive 90/385/EEC of 1990.[10] The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998.[11]
The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB). The Annex ZA harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/745) of 2017.[12] The Annex ZB harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/746) of 2017.[13]
In 2013, a technical report ISO/TR 24971[14] was published by ISO TC 210 to provide expert guidance on the application of this standard. The second edition of ISO 24971 was published in 2020 and contains some of the informative annexes from the second edition of ISO 14971.[15]
For example:
The third edition of the standard from 2019 differs from 14971:2007 not only by a new chapter structure, but also by focus on the benefit-risk ratio. For this, the concept of (medical) benefit is now defined. In addition, there is a stronger focus on the "information from the production and the downstream phases". Some explanations or appendices from the previous edition are outsourced in ISO / TR 24971:2019.
دوون الإحداثيات 43°16′43″N 96°13′55″W / 43.278611111111°N 96.231944444444°W / 43.278611111111; -96.231944444444 تاريخ التأسيس 1892 تقسيم إداري البلد الولايات المتحدة[1] التقسيم الأعلى مقاطعة ليون خصائص جغرافية المساحة 1.485169 كيلومتر مربع1.485178 كيلومتر مربع (1 أبريل 2010) …
?Колібрі-білогуз Колібрі-білогуз бронзовохвостий (Chalybura urochrysia) Біологічна класифікація Домен: Еукаріоти (Eukaryota) Царство: Тварини (Animalia) Тип: Хордові (Chordata) Клас: Птахи (Aves) Ряд: Серпокрильцеподібні (Apodiformes) Родина: Колібрієві (Trochilidae) Підродина: Колібрині (Trochilinae) Триба: Trochilini Рід…
LareareaPulau LareareaLareareaTampilkan peta Sulawesi SelatanLareareaTampilkan peta SulawesiLareareaTampilkan peta IndonesiaLareareaTampilkan peta Asia TenggaraGeografiLokasiTeluk BoneAsia TenggaraSamudra HindiaKoordinat5°4′14.378″S 120°23′32.373″E / 5.07066056°S 120.39232583°E / -5.07066056; 120.39232583KepulauanKepulauan Sembilan, Kepulauan Sunda Besar (Pulau Sulawesi dan Pulau-pulau Kecil di Sekitarnya), Kepulauan IndonesiaDibatasi olehTeluk BonePemerintaha…
Questa voce o sezione sugli argomenti mitologia romana e mitologia greca non cita le fonti necessarie o quelle presenti sono insufficienti. Puoi migliorare questa voce aggiungendo citazioni da fonti attendibili secondo le linee guida sull'uso delle fonti. Segui i suggerimenti dei progetti di riferimento 1, 2. Le corrispondenze tra divinità greche e romane sono il segno più visibile di un continuum religioso e culturale tra le popolazioni che hanno orbitato intorno al Mar Mediterraneo e ch…
ملخص معلومات الملف وصف هذه صورة صندوق معلومات مقالة : روبرت دريفوس مصدر المنشور الأصلي: غير معروف المصدر الحالي: Here تاريخ pre-2009 منتج هذا الملف لا يمتلك معلومات المنتج، وربما تنقصه بعض المعلومات الأخرى. يجب أن تحتوي الملفات على معلومات موجزة حول الملف لإعلام الآخرين بالمحتو…
Sir William Robertson, BtLetjen Sir William Robertson pada 1915JulukanWullyLahir(1860-01-29)29 Januari 1860Welbourn, Lincolnshire, InggrisMeninggal12 Februari 1933(1933-02-12) (umur 73)London, InggrisDikebumikanBrookwood CemeteryPengabdianBritania RayaDinas/cabangBritish ArmyLama dinas1877–1920PangkatMarsekal lapanganKomandanBritish Army of the RhineEastern CommandChief of the Imperial General StaffStaff College, CamberleyPerang/pertempuranEkspedisi ChitralPerang Boer KeduaPerang Dun…
Gottfried Leibniz, filósofo alemán que acuñó el término teodicea. La teodicea (del griego θεός -dios- + δίκη -justicia-) es una rama de la filosofía cuyo objetivo es la demostración racional de la existencia de Dios mediante razonamientos, así como la descripción análoga de su naturaleza y atributos. Etimológicamente hablando, Teodicea es «justificación de Dios», y por tanto se enmarca en el ámbito más amplio de la teología natural, aunque a menudo estos dos términos se…
Baltasar de Marradas y Vich Información personalNacimiento 28 de noviembre de 1560 Valencia (España) Fallecimiento 12 de agosto de 1638 (77 años)Praga (Reino de Bohemia) Información profesionalOcupación Líder militar y caballero Rama militar Ejército del Sacro Imperio Romano Germánico Rango militar Mariscal Conflictos Guerra Larga Firma Escudo [editar datos en Wikidata] Baltasar de Marradas y Vich, (Valencia, 28 de noviembre de 1560-Praga, 12 de agosto de 1638) fue un noble y m…
List of Disney films redirects here. For a broader list of Disney films, see Lists of Walt Disney Studios films. This is a list of films produced by and released under the Walt Disney Pictures banner (known as that since 1983, with Never Cry Wolf as its first release) and films released before that under the former name of the parent company, Walt Disney Productions (1929–1983). Most films listed here were distributed theatrically in the United States by the company's distribution division, Wa…
Partai Demokrasi Kebangsaan Ketua umumM. Ryaas RasyidSekretaris JenderalRapiddin HamarungDibentuk23 Juli 2002 (sebagai PPDK);28 Oktober 2007 (sebagai PDK)Kantor pusatJl. Pejaten Barat No.30 Pasar Minggu, Jakarta Selatan, DKI JakartaIdeologiPancasilaKursi di DPR (2009)-Situs webhttp://www.pdk.or.idPolitik IndonesiaPartai politikPemilihan umum Logo PPDK pada Pemilu 2004 Partai Demokrasi Kebangsaan (PDK), sebelumnya bernama Partai Persatuan Demokrasi Kebangsaan (PPDK), adalah salah satu p…
Part of the First World War For other uses, see Battle of Texel (disambiguation). Battle off TexelPart of the First World WarA sketch of the battle by one of the participants.Date17 October 1914Location50 nautical miles (58 mi; 93 km) off Texel, the Netherlands, North Sea53°17′21″N 3°28′27″E / 53.28917°N 3.47417°E / 53.28917; 3.47417Result British victoryBelligerents United Kingdom GermanyCommanders and leaders Cecil Fox Georg Thiele …
Aspect of history A cylindrical bronze wine container made during the late Shang dynasty (c. 1600 – c. 1050 BCE); such items were excavated by gentry scholars of the Song dynasty (960–1279).[1] Part of a series on theHistory of China Timeline Dynasties Historiography Prehistoric Paleolithic Neolithic (c. 8500 – c. 2000 BCE) Yellow, Yangtze, and Liao civilization Ancient Xia (c. 2070 – c. 1600 BCE) Shang (c. 1600 – c.…
Census-designated place in California, United StatesMontaracensus-designated placeMontara State Beach in MontaraLocation in San Mateo County and the state of CaliforniaMontaraLocation in the United StatesCoordinates: 37°32′23″N 122°30′23″W / 37.53972°N 122.50639°W / 37.53972; -122.50639CountryUnited StatesStateCaliforniaCountySan MateoArea[1] • Total3.878 sq mi (10.045 km2) • Land3.878 sq mi (10.045 …
Annual Swedish film awards ceremony Guldbagge AwardsCurrent: 57th Guldbagge AwardsThe statuetteAwarded forExcellence in Swedish filmCountrySwedenPresented bySwedish Film InstituteFirst awarded1964WebsiteOfficial website The Guldbagge Awards (Swedish: Guldbaggen, English: The golden scarab) is an official and annual Swedish film awards ceremony honoring achievements in the Swedish film industry. Winners are awarded a statuette depicting a rose chafer, better known by the name Guldbaggen. The awar…
2016 television miniseries Tokyo TrialPromotional posterKanji東京裁判 GenreHistorical dramaWritten byRob W. KingMax MannixToru TakagiKees van BeijnumDirected byPieter VerhoeffRob W. KingStarring Tim Ahern Paul Freeman Serge Hazanavicius Marcel Hensema William Hope Jonathan Hyde Michael Ironside Irrfan Khan Stephen McHattie David K.S. Tse Shinya Tsukamoto Julian Wadham Hadewych Minis Narrated byStacy KeachComposerRobert CarliCountry of origin Japan Canada Netherlands Original languagesJapanes…
NBL1 West awards and honors Championship Champions Individual awards Most Valuable Player Coach of the Year Rookie of the Year (defunct) Grand Final MVP Most Improved Player (defunct) Honours All-NBL1 West First Team All-Defensive Five (defunct) vte The champion teams of the NBL1 West, formerly the State Basketball League (SBL), are determined annually by a grand final weekend hosted by Basketball Western Australia. All grand finals have been played in a one-game championship decider…
2012 film by Lian Lunson Sing Me the Songs That Say I Love You: A Concert for Kate McGarrigleDirected byLian LunsonProduced byLian Lunson Teddy WainwrightExecutive producersMartha WainwrightRufus WainwrightWim WendersProductioncompanyHorse PicturesRelease date April 29, 2012 (2012-04-29) (Sundance London) Sing Me the Songs That Say I Love You: A Concert for Kate McGarrigle is a 2012 documentary film directed by Lian Lunson.[1][2] It follows a memorial concert o…
County in Idaho, United States County in IdahoLatah CountyCountyMoscow Post Office and Courthouse SealLocation within the U.S. state of IdahoIdaho's location within the U.S.Coordinates: 46°50′24″N 116°40′36″W / 46.84°N 116.6767°W / 46.84; -116.6767Country United StatesState IdahoFoundedMay 14, 1888Named forLatah CreekSeatMoscowLargest cityMoscowArea • Total1,077 sq mi (2,790 km2) • Land1,077 sq mi (2,7…
For other ships with the same name, see Japanese ship Hashidate. This article includes a list of general references, but it lacks sufficient corresponding inline citations. Please help to improve this article by introducing more precise citations. (March 2021) (Learn how and when to remove this template message) JS Hashidate History Japan Name Hashidate (はしだて) NamesakeHashidate (1939) BuilderKawasaki Heavy Industries Cost¥69 billion Laid down26 October 1998 Launched26 July 1999 Commissi…
Sheet music cover Mandy is a popular song by Irving Berlin, published in 1919.[1][2][3] History Mandy was originally used for an Army-themed musical revue called Yip Yip Yaphank during World War I. For the number, soldiers in the show dressed in blackface and in drag.[4] This song and chorus line was also re-created for the 1942 play and the 1943 Warner Brothers film This Is The Army. The number became a hit when it was re-used in the Ziegfeld Follies of 1919, whe…
Lokasi Pengunjung: 3.135.220.57