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Prüfbericht-Nr.: 60383369 002 Auftrags-Nr.: 190126426 Seite 1 von 14 Test Report No.: Order No.: Page 1 of 14
Kunden-Referenz-Nr.: N/A Auftragsdatum: 2020-05-25 Client Reference No.: Order date: Yangxi County Hope Health Biological Technology Co., Ltd. Auftraggeber: Client: Zhongshan Torch (Yangxi) Industrial Transfer Park, Yangxi County, Yangjiang City, Guangdong Province, China. Prüfgegenstand: DISPOSABLE FLAT FACE MASK Test item: Bezeichnung / Typ-Nr.: Identification / Type No.: HHFM-M001
Auftrags-Inhalt: Order content: Type test
Prüfgrundlage: EN 14683:2019+AC:2019(except for Clause 5.2.6 Biocompatibility) Test specification:
Wareneingangsdatum: Date of receipt: 2020-07-02
Prüfmuster-Nr.: Test sample No.: Engineering sample
Prüfzeitraum: Testing period: 2020-07-02 to 2020-07-15 Ort der Prüfung: See page 3 Place of testing: Prüflaboratorium: TÜV Rheinland (China) Ltd. Testing laboratory: Prüfergebnis*: Pass Test result*:
geprüft von / tested by: kontrolliert von / reviewed by:
2020-07-21 Mengdi Zhang / Project Engineer 2020-07-21 Han Dong / Reviewer
Datum Name / Stellung Unterschrift Datum Name / Stellung Unterschrift Date Name / Position Signature Date Name / Position Signature
Sonstiges / Other: The test report consists of EN 14683 test report including this cover page (14 pages). Clause 5.2.6 Biocompatibility is not evaluated in this test report.
Zustand des Prüfgegenstandes bei Anlieferung: Prüfmuster vollständig und unbeschädigt Condition of the test item at delivery: Test item complete and undamaged * Legende: 1 = sehr gut 2 = gut 3 = befriedigend 4 = ausreichend 5 = mangelhaft P(ass) = entspricht o.g. Prüfgrundlage(n) F(ail) = entspricht nicht o.g. Prüfgrundlage(n) N/A = nicht anwendbar N/T = nicht getestet Legend: 1 = very good 2 = good 3 = satisfactory 4 = sufficient 5 = poor P(ass) = passed a.m. test specification(s) F(ail) = failed a.m. test specification(s) N/A = not applicable N/T = not tested Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfmuster und darf ohne Genehmigung der Prüfstelle nicht auszugsweise vervielfältigt werden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens.
This test report only relates to the a. m. test sample. Without permission of the test center this test report is not permitted to be duplicated in extracts. This test report does not entitle to carry any test mark.
TUV Rheinland(China) Ltd. Room 303,1st Area Chuang Xin Building No.B,No.12,Hong Da Road (north) Economic Technological Development Area Beijing 100176 P.R.China
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EN 14683:2019+AC: 2019 Medical face masks Requirements and test methods Report Reference No...... : 60383369 002 Date of issue ...... : See cover page Total number of pages ...... : See cover page
Testing Laboratory ...... : TÜV Rheinland (China) Ltd. Address ...... : Unit 707, AVIC Building, No. 10B, Central Road, East 3rd Ring Road,Chaoyang District, Beijing 100022, P.R.China A lican name ...... : Yangxi County Hope Health Biological Technology Co., Ltd. Address ...... : Zhongshan Torch (Yangxi) Industrial Transfer Park, Yangxi County, Yangjiang City, Guangdong Province, China. Test specification: Standard ...... : EN 14683:2019+AC:2019 Test procedure ...... : Type test Non- anda d e me h d ..: N/A Test Report Form No...... : EN 14683:2019+AC:2019_A Test Report Form Originator ...... : TÜV Rh (SZ) Master TRF ...... : 2020-03 Test item description ...... : DISPOSABLE FLAT FACE MASK Trade Mark ...... :
Manufacturer ...... : Yangxi County Hope Health Biological Technology Co., Ltd. Zhongshan Torch (Yangxi) Industrial Transfer Park, Yangxi County, Yangjiang City, Guangdong Province, China. Model/Type reference ...... : HHFM-M001 Classification ...... : Type IIR
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12 Page 3 of 14 Report No. 60383369 002
List of Attachments (including a total number of pages in each attachment): None
Summary of testing: Tests performed (name of test and test clause): Testing location: Clause 5.1.1 Materials and construction TÜV Rheinland (China) Ltd. Clause 5.1.2 Design Unit 707, AVIC Building, No. 10B, Central Road, East 3rd Ring Road,Chaoyang District, Beijing 100022, P,R,China
Clause 5.2.2: Bacterial filtration efficiency (BFE) Pony Testing Group Shanghai Co.,Ltd. Clause 5.2.3: Breathability 2/3/4/6/F., Building 35, No.680, Guiping Clause 5.2.4: Splash resistance Road, Xuhui District, Shanghai, China Clause 5.2.5: Microbial cleanliness (Bioburden)
Note: All tests listed as above have been conducted in the competent external lab under the supervision of a TUV engineer
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12
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Copy of marking plate
The artwork below may be only a draft. Label & Box:
Label & Box:
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12
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Inner package:
Over view of Inner package:
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12
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Front view of face mask:
Back view of face mask:
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12
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Open view of face mask:
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12
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Testing Date of receipt of test item(s) ...... : See cover page Dates of tests performed ...... : See cover page Possible test case verdicts: - test case does not apply to the test object ...... : N/A - test object does meet the requirement ...... : P (Pass) - test object was not evaluated for the requirement .... : N/E (collateral standards only) - test object does not meet the requirement ...... : F (Fail)
General remarks: "(See Attachment #)" refers to additional information appended to the report. "(See appended table)" refers to a table appended to the report. The tests results presented in this report relate only to the object tested. This report shall not be reproduced except in full without the written approval of the testing laboratory. List of test equipment must be kept on file and available for review. Additional test data and/or information provided in the attachments to this report.
Throughout this report a comma / point is used as the decimal separator.
Name and address of factory (ies) ...... : Yangxi County Hope Health Biological Technology Co., Ltd. Zhongshan Torch (Yangxi) Industrial Transfer Park, Yangxi County, Yangjiang City, Guangdong Province, China. General product information: The submitted samples are type IIR, DISPOSABLE FLAT FACE MASK which is intended to be worn to protect against the spread or transmission of infectious germs during surgical interventions in operating theatres and other medical facilities. The main aim is to protect the patient against infectious germs. In addition, in certain situations the wearer should be protected against splashes of potentially contaminated liquids and viable particles. It is a non-sterile product.
Clause 5.2.6 Biocompatibility is not evaluated in this test report. The test results are for reference only. Relevant certification may be needed if the mask is intended to be sold in Europe.
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12
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EN 14683:2019+AC:2019 Clause Requirement + Test Result - Remark Verdict
4 Classification P Medical face masks specified in this European Type IIR P Standard are classified into two types (Type I and Type II) according to bacterial filtration efficiency whereby Type II is further divided according to whether or not the mask is splash resistant. The 'R' signifies splash resistance. 5 Requirements P 5.1 General P 5.1.1 Materials and construction P The medical face mask is a medical device, generally High quality non-woven fabric, P composed of a filter layer that is placed, bonded or meltblown fabric moulded between layers of fabric. The medical face mask shall not disintegrate, split or Complied P tear during intended use. In the selection of the filter and layer materials, Complied P attention shall be paid to cleanliness. 5.1.2 Design P The medical face mask shall have a means by which it Fitted closely over nose. P can be fitted closely over the nose, mouth and chin of the wearer and which ensures that the mask fits closely at the sides. Medical face masks may have different shapes and With nose clip. P constructions as well as additional features such as a face shield (to protect the wearer against splashes and droplets) with or without anti-fog function, or a nose bridge (to enhance fit by conforming to the nose contours). 5.2 Performance requirements P 5.2.1 General P All tests shall be carried out on finished products or P samples cut from finished products. 5.2.2 Bacterial filtration efficiency (BFE) P When tested in accordance with Annex B, the BFE of The Bacterial Filtration Efficiency P the medical face mask shall conform to the minimum 98% value given for the relevant type in Table 1.1 1.2. See appended Table 5.2.2 For thick and rigid masks such as rigid duckbill or cup Not such masks N/A masks the test method may not be suitable as a proper seal cannot be maintained in the cascade impactor. In these cases, another valid equivalent method shall be used to determine the BFE. When a mask consists of two or more areas with N/A different characteristics or different layer-composition, each panel or area shall be tested individually.
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EN 14683:2019+AC:2019 Clause Requirement + Test Result - Remark Verdict
The lowest performing panel or area shall determine N/A the BFE value of the complete mask 5.2.3 Breathability P When tested in accordance with Annex C, the The differential pressure <60 P differential pressure of the medical face mask shall Pa/cm2 conform to the value given for the relevant type in Table 2.1 2.2. See appended Table 5.2.3 If the use of a respiratory protective device as face No such respiratory protective N/A mask is required in an operating theatre and/or other device provided medical settings, it might not fulfil the performance requirements with regard to differential pressure as defined in this European Standard. In such case, the device should fulfil the requirement as specified in the relevant Personal Protective Equipment (PPE) standard(s). 5.2.4 Splash resistance P When tested in accordance with ISO 22609:2004 the See appended Table 5.2.4 P resistance of the medical face mask to penetration of splashes of liquid shall conform to the minimum value given for Type IIR in Table 1. 5.2.5 Microbial cleanliness (Bioburden) P When tested according to EN ISO 11737-1:2018 the The bioburden of the medical P mask was CFU/g b b de f he ed ca a ha be 30 CFU/g 30 tested (see Table 3.1 3.2). See appended Table 5.2.5 5.2.6 Biocompatibility N/E According to the definition and classification in EN ISO Not evaluated in this test report. N/E 10993-1:2009, a medical face mask is a surface device with limited contact. The manufacturer shall complete the evaluation of the N/E medical face mask according to EN ISO 10993-1:2009 and determine the applicable toxicology testing regime. The results of testing should be documented according N/E to the applicable parts of the EN ISO 10993 series. The test results shall be available upon request. N/E 6 Marking, labelling and packaging P Annex I, §13, of the Medical Devices Directive Considered P (93/42/EEC) or Annex I, §23, of the Medical Device Regulation (EU) 2017/745 specifies the information that should be specified on the packaging in which the medical face mask is supplied. The following information shall be supplied: P a) number of this European Standard; EN 14683:2019 Marked on the P label b) type of mask (as indicated in Table 1). Type IIR Marked on the label P EN ISO 15223-1:2016 and EN 1041:2008+A1:2013 Compliance P should be considered. QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12
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EN 14683:2019+AC:2019 Clause Requirement + Test Result - Remark Verdict
5.2.2 TABLE: Bacterial filtration efficiency (BFE) P Batch/ Test Dimension test area Flow rate Mean of the Mean plate BFE for Remarks lot no.: Speci of the test (cm2) (l/min) total plate count of the each test -men specimen counts of the negative specimen no.: L x W (mm two positive controls (%) x mm) controls
2020050 1 155×135 95 28.3 2077 0 99.3 98 1099 2 155×135 95 28.3 2077 0 99.6 98 3 155×135 95 28.3 2077 0 99.5 98 4 155×135 95 28.3 2077 0 99.4 98 5 155×135 95 28.3 2077 0 99.5 98 Supplementary information: 1, Each specimen was conditioned at 21.1 °C and 85.0 % relative humidity for 4 h to bring them into equilibrium with atmosphere prior to testing. 2, The side of the test specimen was facing towards the challenge aerosol: face
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EN 14683:2019+AC:2019 Clause Requirement + Test Result - Remark Verdict
5.2.3 TABLE: Breathability (Differential pressure) P Batch/ Test Differential pressure for The averaged Flow rate Remarks lot no.: Specimen each test area differential (l/min) number- (Pa/cm2) pressure for Test area each test number specimen (Pa/cm2) 202005 1-1 46.7 47.3 8 <60 01099 1-2 45.5 8 <60 1-3 48.3 8 <60 1-4 48.5 8 <60 1-5 47.3 8 <60 2-1 49.8 49.4 8 <60 2-2 49.0 8 <60 2-3 49.5 8 <60 2-4 50.3 8 <60 2-5 48.2 8 <60 3-1 50.2 49.9 8 <60 3-2 50.1 8 <60 3-3 48.8 8 <60 3-4 48.9 8 <60 3-5 51.4 8 <60 4-1 49.7 49.7 8 <60 4-2 49.4 8 <60 4-3 48.7 8 <60 4-4 49.3 8 <60 4-5 51.3 8 <60 5-1 48.3 48.3 8 <60 5-2 50.0 8 <60 5-3 48.8 8 <60 5-4 47.7 8 <60 5-5 46.5 8 <60 Supplementary information: Each specimen was conditioned at 21.4 °C and 85.6 % relative humidity for 4 h to bring them into equilibrium with atmosphere prior to testing.
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EN 14683:2019+AC:2019 Clause Requirement + Test Result - Remark Verdict
5.2.4 TABLE: Splash resistance P Batch/ lot no.: Test mask no.: The material of tested mask Test result Remarks (Pass/fail)
20200501099 1 High quality non-woven fabric, meltblown Pass - fabric 2 Pass - 3 Pass - 4 Pass - 5 Pass - 6 Pass - 7 Pass - 8 Pass - 9 Pass - 10 Pass - 11 Pass - 12 Pass - 13 Pass - 14 Pass - 15 Pass - 16 Pass - 17 Pass - 18 Pass - 19 Pass - 20 Pass - 21 Pass - 22 Pass - 23 Pass - 24 Pass - 25 Pass - 26 Pass - 27 Pass - 28 Pass - 29 Pass - 30 Pass - 31 Pass - QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12
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EN 14683:2019+AC:2019 Clause Requirement + Test Result - Remark Verdict
32 Pass - Supplementary information: 1, Each specimen was conditioned at 24 °C and 85 % relative humidity for 4 h to bring them into equilibrium with atmosphere prior to testing. 2, The description of target area tested: the centre of the specimen 3, Any technique used to enhance visual detection of synthetic blood: cotton absorbent swab 4, The temperature and relative humidity for testing: 24 °C and 80 % 5, Description of any pre-treatment techniques used:\
5.2.5 TABLE: Microbial cleanliness (Bioburden) P Batch/ lot no.: Mask(under Weight of Total bioburden Remarks test) no.: each mask per individual (g) mask (CFU/g)
20200501099 1 2.72 19 30 2 2.77 17 30 3 2.81 16 30 4 2.76 4 30 5 2.79 11 30 Supplementary information:/
END OF TEST REPORT
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12
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Obligation to Notify pursuant to §§ 25 and 30 (2) Medical Devices Act, MPG Formblatt für Medizinprodukte, außer In-vitro-Diagnostika Form for Medical Devices except In Vitro Diagnostic Medical Devices Zuständige Behörde / Competent authority Code DE/CA20 Bezeichnung / Name Bezirksregierung Düsseldorf, Dezernat 24 Staat / State Land / Federal state Deutschland Nordrhein-Westfalen Ort / City Postleitzahl / Postal code Düsseldorf 40474 Straße, Haus-Nr. / Street, house no. Cecilienallee 2 Telefon / Phone Telefax / Fax +49-211-4750 +49-211-4752671 E-Mail / E-mail [email protected] Anzeige / Notification Registrierdatum bei der zuständigen Behörde Registriernummer / Registration number Registration date at competent authority DE/CA20/01-Caretechion-174/20 14.07.2020 Typ der Anzeige / Notification type Erstanzeige / Initial notification Änderungsanzeige / Notification of change Widerrufsanzeige / Notification of withdrawal Frühere Registriernummer bei Änderungs- und Widerrufsanzeige Previous registration number if notification has been changed or withdrawn Anzeigender nach § 25 MPG / Reporter pursuant to § 25 Medical Devices Act, MPG Hersteller / Manufacturer Bevollmächtigter / Authorised Representative Einführer / Importer Verantwortlicher für das Zusammensetzen von Systemen oder Behandlungseinheiten nach § 10 Abs. 1 und 2 MPG \ Assembler of systems or procedure packs pursuant to § 10 (1) and (2) Medical Devices Act, MPG Betrieb oder Einrichtung (aufbereiten) nach § 25 Abs. 1 MPG i. V. m. § 4 Abs. 2 MPBetreibV Institution (processing) pursuant to § 25 (1) Medical Devices Act, MPG in connection with § 4 (2) MPBetreibV Betrieb oder Einrichtung (sterilisieren) nach § 25 Abs. 2 i. V. m. § 10 Abs. 3 MPG Institution (sterilizing) pursuant to § 25 (2) in connection with § 10 (3) Medical Devices Act, MPG - 1 - Anlage 1 (zu § 4 Abs. 1 Nr. 1 DIMDIV) Formularnummer 00310043 Anzeigender / Reporting organisation (person) Code DE/0000048026 Bezeichnung / Name Caretechion GmbH Staat / State Land / Federal state Deutschland Nordrhein-Westfalen Ort / City Postleitzahl / Postal code Düsseldorf 40474 Straße, Haus-Nr. / Street, house no. Niederrheinstraße 71 Telefon / Phone Telefax / Fax +49 211 300 366 18 E-Mail / E-mail [email protected] Hersteller / Manufacturer Bezeichnung / Name Yangxi County Hope Health Biological Technology Co., Ltd. Staat / State CN Ort / City Postleitzahl / Postal code Yangjiang 529800 Straße, Haus-Nr. / Street, house no. Zhongshan Torch (Yangxi) Industrial Transfer Park, Yangxi County Telefon / Phone Telefax / Fax +86 662-5887298 E-Mail / E-mail [email protected] Sicherheitsbeauftragter für Medizinprodukte nach § 30 Abs. 2 MPG 9) Safety officer for medical devices pursuant to § 30 (2) Medical Devices Act, MPG Bezeichnung / Name Ingo Becker Staat / State Land / Federal state Deutschland Nordrhein-Westfalen Ort / City Postleitzahl / Postal code Erftstadt 50374 Straße, Haus-Nr. / Street, house no. Elly-Heuss-Knapp-Weg, 26 Telefon / Phone Telefax / Fax 022356892667 E-Mail / E-mail [email protected] - 2 - Anlage 1 (zu § 4 Abs. 1 Nr. 1 DIMDIV) Formularnummer 00310043 Vertreter / Deputy (optional) Bezeichnung / Name Telefon / Phone Telefax / Fax E-Mail / E-mail Erstanzeige / Initial notification Änderungsanzeige / Notification of change - 3 - Anlage 1 (zu § 4 Abs. 1 Nr. 1 DIMDIV) Formularnummer 00310043 Medizinprodukt (Erstmaliges Inverkehrbringen) / Medical device (First placing on the market) Klasse / Class I I - steril / sterile I - mit Messfunktion / with measuring function I - steril und mit Messfunktion / sterile and with measuring function IIa IIb III III - hergestellt unter Verwendung von Gewebe tierischen Ursprungs im Sinne der Verordnung (EU) Nr. 722/2012 manufactured utilising tissues of animal origin in terms of Commission Regulation (EU) No 722/2012 Aktives implantierbares Medizinprodukt / Active implantable medical device Aktives implantierbares Medizinprodukt - hergestellt unter Verwendung von Gewebe tierischen Ursprungs im Sinne der Verordnung (EU) Nr. 722/2012 Active implantable medical device - manufactured utilising tissues of animal origin in terms of Commission Regulation (EU) No 722/2012 App (Software auf mobilen Endgeräten) ja / yes nein / no Nummer(n) der Bescheinigung(en) / Certificate number(s) Handelsname des Produktes / Trade name of the device Produktbezeichnung / Name of device Disposable Flat Face Mask Nomenklaturcode / Nomenclature code 12-447 Nomenklaturbezeichnung / Nomenclature term Maske Kategoriecode / Category code 10 Kategorie / Category Produkte zum Einmalgebrauch Kurzbeschreibung deutsch / German short description Das Produkt soll zum Schutz vor der Ausbreitung oder Übertragung infektiöser Keime bei chirurgischen Eingriffen in Operationssälen und anderen medizinischen Einrichtungen getragen werden. Hauptziel ist es, den Patienten vor infektiösen Keimen zu schützen. Darüber hinaus sollte der Träger in bestimmten Situationen vor Spritzern potenziell kontaminierter Flüssigkeiten und lebensfähiger Partikel geschützt werden. Kurzbeschreibung englisch / English short description The product is intended to be worn to protect against the spread or transmission of infectious germs during surgical interventions in operating theatres and other medical facilities. The main aim is to protect the patient against infectious germs. In addition, in certain situations the wearer should be protected against splashes of potentially contaminated liquids and viable particles. - 4 - Anlage 1 (zu § 4 Abs. 1 Nr. 1 DIMDIV) Formularnummer 00310043 Medizinprodukte (Aufbereiten) / Medical devices (Reprocessing) Semikritische Medizinprodukte / Semicritical medical devices Gruppe A / Group A Gruppe B / Group B Kritische Medizinprodukte / Critical medical devices Gruppe A / Group A Gruppe B / Group B Gruppe C / Group C Nummer der Bescheinigung / Certificate number Sterilisationsverfahren / Sterilisation procedures Dampfsterilisation / Steam sterilisation Gassterilisation / Gas sterilisation Strahlensterilisation / Radiation sterilisation andere / others Angewandtes Verfahren / Applied procedure Ich versichere, dass die Angaben nach bestem Wissen und Gewissen gemacht wurden. I affirm that the information given above is correct to the best of my knowledge. Ort Datum City Düsseldorf Date 2020-06-30 ...... Name JIAN WANG ...... Unterschrift Signature Bearbeitungsvermerke / Processing notes Nur von der zuständigen Behörde auszufüllen / To be filled in only by the competent authority Bearbeiter / Person responsible Telefon / Phone Carolyn Jänsch 0211 475-5254 - 5 -