NOTICES FROM MEMBER STATES
EN ISO 10993-10:2002. Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) ...
http://www.luc.pl/download/Wykaz_EN_zharm_D90_385_EWG_2009_02_19.pdf
First part of summary table (includes the references of the ...
EN ISO 10993-10:2002. Biological evaluation of medical devices - Part 10: Tests ... 10993-. 10:1995. Date Expired. (31.3.2003). EN ISO 10993-10:2002/A1:2006 ...
http://kor1.asiaitc.com/data/upload/AIMDD _ Harmonized Standard_071105051225.pdf?PHPSESSID=d7343174b6cc5cfd5e95b870edcd5e8b
DRAFT Medical
Device Standard Order - biological safety
26 Jun 2008 ... ISO 10993-10:2002 Biological evaluation of medical devices - Part 10 Tests for irritation and delayed-type hypersensitivity ...
http://www.tga.gov.au/devices/drmdsobiol.pdf
ANSI/AAMI/ISO 10993-11:2006, Biological evaluation
of medical ...
1 Dec 2006 ... ISO 10993-10:2002 and Amendment. 1:2006. ANSI/AAMI BE78:2002. ANSI/AAMI BE78:2002/A1:2006. Minor technical variations. Identical ...
http://marketplace.aami.org/eseries/scriptcontent/docs/Preview Files\10993110610preview.pdf
American National Standard ANSI/AAMI
BE78:2002/A1:2006(R)2008
Biological evaluation of medical devices—Part 10: Tests for irritation and delayed-type hypersensitivity. (identical adoption of ISO 10993-10:2002/Amendment ...
http://marketplace.aami.org/eseries/scriptcontent/docs/be78a0812.pdf
LIST OF INTERNATIONAL STANDARDS FOR MEDICAL DEVICES NO STANDARD
...
EN ISO 10993-10: 2002. Biological evaluation of medical devices – Part 10: Tests for irritation and sensitization (ISO 10993-10:2002). 37. EN ISO 10993-12 ...
http://www.mdb.gov.my/mdb/documents/standards/international standard.pdf
Lubricent Hydrophilic Coatings.qxp
ISO 10993-10:2002 Biological Evaluation of. Medical Devices Part 10: Test for Irritation and Delayed-type Hypersensitivity, pp.23-25. ISO 10993-12:2002 ...
http://www.jvs.de/images/stories/Harland/pdf/LubricentTech_Data_Brochure_electronic_6-6-07.pdf
Standards for Active Implantable Medical Devices (90/385/EEC)
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity. (ISO 10993-10:2002). BS EN ISO 10993-. 10:2002 ...
http://www.mhra.gov.uk/home/groups/es-era/documents/websiteresources/con2024926.pdf
Standards for Active Implantable Medical Devices (90/385/EEC)
medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity. (ISO 10993-10:2002). BS EN ISO 10993-. 10:2002 (amendment incorporated) ...
http://www.mhra.gov.uk/home/groups/es-era/documents/websiteresources/con2030327.pdf
Product 3590 ISO Cert.pdf
Hypersensitivity:ISO 10993-10, 2002. These studies are in conformance to all applicable laws and regulations. Specific regulatory ...
http://www.henkel.de/de/content_data/ISO_10993_Certificate__Loctite_3590_I102904.pdf
Product 3589 ISO Cert.pdf
Hypersensitivity: ISO 10993-10, 2002. These studies are in conformance to all applicable laws and regulations. Specific regulatory ...
http://www.henkel.de/de/content_data/ISO_10993_Certificate__Loctite_3589_I032405.pdf
IIT BOMBAY
CENTRAL LIBRARY Annual Reports Standards
RISO 10993 - 10 : 2002 A66956. Biological evaluation of medical devices - part 10 : Tests for irritation and delayed-type hypersensitivity ...
http://www.library.iitb.ac.in/archives/p-may1.pdf
CERTIFICATE
Method: Maximisation Test (Magnusson-Kligman), EN ISO 10993-10: 2002, (6.3) „Tests for irritation and delayed-type hypersensitivity“, EN ISO 10993-12: 2002, ...
http://www.wieland-dental.de/uploads/tx_pxwldownloads/Dentanem_GB_44231.pdf
CERTIFICATE
EN ISO 10993-10: 2002, (6.3) "Tests for irritation and sensitization",. EN ISO 7405: 1997 (5.4.b)5|), OECD 406-92, and Directive 92/69 EEC, B.6. ...
http://www.wieland-dental.de/uploads/tx_pxwldownloads/Porta_SmartXXL_E.pdf
Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9
...
ISO 10993 - 10: 2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed - type hypersensitivity. 13. ISO 10993: 11: 1996, ...
http://tominet.jp/yakuji/webfile/t1_0ed2cde97f0fc3d8b00afd4438213c88.pdf
ISO
10993-1
[10]. ISO 10993-10:2002, Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity ...
http://media.library.ku.edu.tr/Standards/ISO_10993-1.pdf
Certificate
ISO 10993-10: 2002, (6.3) “Tests for irritation and delayed-type hypersensitivity”, ISO 7405: 1997 (5.4.b)5), OECD 406-92 and Directive 92/69 EEC, B.6. ...
http://www.bego.com/pdf/de_82738_2009_bz_en.pdf
イメージ印刷
2.2 ISO 10993-10(2002) Biological evaluation of medical devices—Part 10: Tests for irritation and delayed-type hypersensitivity. 2.3 ISO 10993-12 (2002) ...
http://dmd.nihs.go.jp/iso-tc194/guide_sankou.pdf
Page 1 Page 2
Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 ...
ISO 10993-10: 2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed - type hypersensitivity. 13.ISO 10993-11: 1996, ...
http://dmd.nihs.go.jp/jisedai/heart/heart18_H.pdf
Est_Implant_32
(Magnusson-KNgman), EN ISO 10993-10: 2002, (6.3) «Tests for irritation and delayed-type hypersensitivity», EN ISO 10993-12: 2002, EN ISO 7405: 1997 ...
http://www.daishintrading.co.jp/pdf/cm_fiketo/Est_Implant_32.pdf
TDXiKQN
Devices - Part 10: Irritation and Delayed-type Hypersensitivity, ISO 10993-10, 2002, as amended 2006. ACUTE SYSTEMIC INJECTION (ISO): The puipose of this ...
http://hybris.cms.henkel.com/medias/sys_master/8504059044488416.pdf
Product 3971 ISO Cert_1.pdf
Reference: Biological Evaluation of Medical Devices - Part 10: Irritation and Delayed- type Hypersensitivity, ISO 10993-10, 2002. ...
http://hybris.cms.henkel.com/medias/sys_master/8504059044529936.pdf
Progress File
15 Sep 2006 ... I.S. EN ISO 10993-10:2002/A1:2006. 32. Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type ...
http://www.nsai.ie/uploads/file/PUB15092006.pdf
Sin
título-1
SENSITIZING. SAM2817I 2. Skin Irritation Test. (ISO 10993-10: 2002). NON IRRITANT. ANDROPENIS. GOLD. Cytotoxicity -. Elution Test. (ISO 10993-5: 1999) ...
http://www.aumentaromeupenis.com/pdf/BiotestGeneral.pdf
Product 3201 ISO Cert.pdf
10: Irritation and Delayed-type Hypersensitivity, ¡SO 10993-10, 2002. ACUTE SYSTEMIC INJECTION (ISO): The purpose of this assay is to evaluate the test ...
http://www.loctite.de/de/content_data/ISO_10993_Certificate__Loctite_3201_I110404.pdf
4304-1.pdf
10: Irritation and Delaycd-type Hypersensitivity, ISO 10993-10, 2002. ACUTE SYSTEMIC INJECTION (ISO): The purpose of this assay is to evaluate the test ...
http://www.loctite.de/de/content_data/ISO_10993_Certificate__Loctite_4304_I103103.pdf
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...
ISC,10993 - 10: 2002, Biological evaluation of medical devices - Part 10-. 13 ISO OIT- nritatl0n and delayed * tyPe. T t f ;1996'Blological evaiuation °f ...
http://www.pref.kyoto.jp/yakujikaisei/resources/1212720063550.pdf
Product 3011 ISO Cert-1.pdf
10: Irritation and Delayed-type Hypersensitivity, ISO 10993-10, 2002. ACUTE SYSTEMIC INJECTION (ISO): The purpose of this assay is to evaluate the test ...
http://www.loctite.cn/cnc/content_data/ISO_10993_Certificate__Loctite_3011_I092503.pdf
4305-1.pdf
10: Irritation and Delayed-type Hypersensitivity, ISO 10993-10. 2002. ACUTE SYSTEMIC INJECTION (ISO): The purpose of this assay is to evaluate the test ...
http://www.loctite.cn/cnc/content_data/ISO_10993_Certificate__Loctite_4305_I103103.pdf
Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9
...
1 ISO 10993-10 (1995) Biological evaluation of medical devices Part 10: Tests for irritation and sensitization. 2.2 ISO 10993-10(2002) Biological evaluation ...
http://www.pmda.go.jp/operations/notice/2003/file/jimu20030319.pdf
THERMOLAST
K
1) Compounds TF3STE and TF6STE successfully tested after USP Class VI and ISO 10993-5. 2) TF6STE successfully tested after ISO 10993-10, 2002 (irritation ...
http://www.kraiburgtpe.com/site/english/pdf/FD_M_e.pdf
THERMOLAST K
3) TF6FMA is certified after USP Class VI and has successfully passed the primary buccal irritation test according to ISO 10993 – 10, 2002 ...
http://www.kraiburgtpe.com/site/english/pdf/FD_CO_1VT_e.pdf
THE AMERICAN
ASSOCIATION FOR LABORATORY ACCREDITATION ACCREDITED ...
5 Jan 2009 ... ISO 10993-10:2002 Biological evaluation of. Japanese Intracutaneous Reactivity Test medical devices – Part 10: Tests for irritation and ...
http://www.a2la.org/scopepdf/2785-01.pdf
5078 Wirobond 280 engl
Kligman), EN ISO 10993-10: 2002, (6.3) “Tests for irritation and delayed-type hypersensitivity”, EN ISO 7405: 1997 (5.4.b)5), OECD 406-92 and Directive 92/ ...
http://www.begocanada.com/download/Bio_Certificates/Wirobond 280, E.pdf
Esteticor
Lumina PF www.cmsa.ch/dental
(Magnusson-Kligman), EN ISO 10993-10: 2002, (6.3) «Tests for irritation and delayed-type hypersensitivity», EN ISO 10993-12: 2002, EN ISO 7405: 1997 ...
http://www.dental-unique.nl/Est_Lumina_PF.pdf
Certificate
tion Test (Magnusson-Kligman), EN ISO 10993-10: 2002, (6.3). «Tests for irritation and delayed-type hypersensitivity»,. EN ISO 10993-12: 2007, ...
http://www.cmsa.ch/SiteCollectionDocuments/Zertifikat_Est_Royal_H.pdf
Testing of :
Primer: 2-TS-96 Hydromer: 3-TS-12 On PEBAX
Part 10: Tests for Irritation and Delayed-type Hypersensitivrty;. IS0 10993-10. 2002. Extraction procedures were based upon the standards set by IS0 10993-1 ...
http://www.hydromer.com/medical/biodatapebax.pdf
Performance, Safety and Compatibility MicrocynTM technology
required for compliance with the ISO 10993-10:2002 standard. In a naive control group. 5 animals from each sex were incorporated. ...
http://www.oculusis.com/europe/hungary/downloads/PSC_Microcyn.pdf
Performance,
Safety and Compatibility Microcyn technology
A test was executed to comply with the ISO 10993-10:2002 standard to determine the ocular irritation potential of Microcyn ...
http://www.oculusis.com/europe/poland/downloads/PSC_Microcyn.pdf
ZOG6
II
Services using rabbits, according to ISO 10993-10:2002. No irritation was evident on intact or abraded skin after 24 or 72 hours. Delayed Hypersensitivity ...
http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063013.pdf
IAN 2
3
2 Jun 2009 ... ISO 10993-10: 2002: Tests for Irritation and Sensitization. 4) Both electrodes distributes electrical current evenly. Differences: ...
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090198.pdf
Scanned Document
ISO 10993-10: 2002. ISO 14937:2000. ISO 11737-1:2006. TGO 50:1995. Biological evaluation of medical devices Part 10: Tests for ...
http://www.bionova.com.au/data/media/documents/Declaration of conformity.pdf
ISO/FDIS
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 10993-10:2002(E). Biological evaluation of medical devices —. Part 10: Tests for irritation and delayed-type ...
http://ecb.jrc.it/classlab/10993-10.pdf
Current standings in the process of standardization of the parts
...
ISO 10993-9: 1999 Framework for the identification no action and quantification of potential degradation products. ISO 10993-10: 2002 Tests for irritation ...
http://akseli.tekes.fi/opencms/opencms/OhjelmaPortaali/ohjelmat/COMBIO/fi/Dokumenttiarkisto/Viestinta_ja_aktivointi/Esitysaineisto/RCCtutkimus.pdf
3675 ISO Cert.pdf
ISO 10993-10, 2002. These studies are in conformance to ail applicable laws and regulations. Specific regulatory requirements include the current Good ...
http://www.citizenship.henkel.de/de/content_data/ISO_10993_Certificate__Loctite_3675_I052504.pdf
Performance, Safety and Compatibility Microcyn Technology
A test was executed to comply with the ISO 10993-10:2002 standard to determine the skin irritation potential of Microcyn™. In this test, on three New ...
http://www.biologiq.nl/UserFiles/Dermacyn Performance, Safety and Compatibility Microcyn Technology(1).pdf
Biomatcrials Laboratory Test Report
ISO 10993-10:2002(E) Tests for irritation and delayed-type hypersensitivity (7.4. Maximization test for delayed hypersensitivity). Report No.: NÇIÏUBML950? ...
http://www.hersmedical.com.tw/MIXIMIZATION SENSITZATION TEST YS-717 Disposable Probe Cover(Thermometer Sheaths).pdf
Commission
communication in the framework of the implementation of ...
EN ISO 10993-10:2002. Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) ...
http://www.uljapan.co.jp/emc/download/mdshirei_hidenki.pdf
Performance, Safety and Compatibility Microcyn Technology
is required for compliance with the ISO 10993-10:2002 standard. In a naive control group 5 animals from each sex were incorporated. These animals remained ...
http://www.mediquestlifesciences.com/sitebuildercontent/sitebuilderfiles/DermacynPerformSafetyBiocompat.pdf
TEST REPORT
NUMBER : THJ0068808 AUTHORIZED BY: ON BEHALF OF ...
ORGANIZATION FOR STANDARDIZATION (ISO 10993-5 BIOLOGICAL EVALUATION OF. MEDICAL DEVICES – PART 5: TESTS FOR In Vitro ... NUMBER ISO 10993-10:2002). ...
http://www.inga.com.tw/User/File/THJ006880801.pdf
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